Leukemia
Conditions
Keywords
Relapsed and Refractory Leukemia
Brief summary
The purpose of this clinical research study was to establish a recommended phase 2 once daily (QD) dose of dasatinib and to assess the efficacy of the investigational drug for relapsed or refractory (resistant to previous treatment) leukemia in children and adolescents. The side effects that this oral investigational drug may have in children, and the levels of the drug in the blood, will be studied at different doses.
Interventions
DRUGDasatinib
Tablets, Oral, If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice). Starting Dose Level of 60 mg/m\^2; Escalated/Dose Level 2 of 80 mg/m\^2. Once daily (QD), as long as clinical benefit was maintained. Intra-participant dose escalation was allowed based on tolerance and on individual response. The starting dose for subsequent participants in a stratum may have been escalated depending on safety, assessed by prior intra-participant dose-escalation, and lack of efficacy in previous participants. Treatment courses were defined as 3 weeks (21 days plus any required delay); for participants who stayed on treatment \> 12 months, courses after 12 months were defined in quartiles of 13 weeks. Participants were to be followed until death or up to 5 years after end-of-treatment (EOT).
Sponsors
Innovative Therapies For Children with Cancer Consortium
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 20 Years
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Ph-positive (Ph+) Chronic Myelogenous Leukemia in chronic, accelerated or blast phase or Ph+ acute lymphoblastic leukemia (ALL) with imatinib-resistant disease or intolerance to imatinib. * Ph-negative acute leukemia in second or subsequent relapse * Age \>1 and \<21 years * Lansky or Karnofsky scale \>60 * Life expectancy \>3 weeks * Adequate hepatic and renal function * Written informed consent
Exclusion criteria
* Subjects for whom potentially-curative therapy was available, including electing immediate \[ie, planned \<45 days\] stem-cell transplantation. Subjects in Stratum 1 were to have had an ongoing identical HLA donor search, and may have discontinued study if a donor became available.) * Subjects with symptomatic central nervous system (CNS) disease (eg, convulsions due to their CNS disease). * Subjects who had not recovered from acute toxicity of previous therapy. * Clinically-significant disorder of platelet function (eg, von Willebrand's disease) or ongoing gastrointestinal bleeding. * Serious uncontrolled medical disorder or active infection * Uncontrolled or significant cardiovascular disease * Use of any investigational agent or any other anticancer agent within 14 days prior to treatment start. * Prior therapy with dasatinib * Subjects taking medications that irreversibly inhibit platelet function or anticoagulants. * Subjects taking certain medications that are accepted to have a risk of causing QTc prolongation. * Women of Child Bearing Potential with a positive pregnancy test prior to study drug administration. * Expected noncompliance, or unable to have regular follow-up due to psychologic, social, familial, or geographic reasons. * Subjects who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (eg, infectious disease) illness must not be enrolled into this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recommended Phase II Dose of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia | From the date of first dose to end-of-treatment (EOT) (Median duration of therapy in months: Stratum 1=24.11 [Range:2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) | The recommended phase 2 dasatinib dose was determined based on efficacy, safety, and pharmacokinetic data obtained at the prespecified dose levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-T) is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration. |
| Number of Participants With BCR-ABL Mutations at End-of-Treatment: Stratum1 Ph+ CP-CML and Stratum2/3 Ph+ ALL or AP/BP-CML | At EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]) | BCR-ABL = These are fused genes found in participants with this type of leukemia. |
| Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline | At baseline (within 3 weeks before initiation of study therapy) | FLT3 and KIT = These are fused genes found in participants with this type of leukemia. |
| Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment | At EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38]) | FLT3 and KIT = These are fused genes found in participants with this type of leukemia. |
| Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | From the date of first dose until at least 30 days after the last dose of study drug (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) | AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 3 = Severe; Grade 4 = Life-threatening or disabling. |
| Number of Participants With Dose-limiting Toxicity (DLT) | From the date of first dose until at least 30 days after the last dose of study drug (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) | DLTs: AEs which were at least possibly drug-related occurring within first 3 weeks of dasatinib therapy (toxicities occurring after 21 days were also considered) and are:- --Any nonhematologic clinically-apparent toxicity of Grade(GR)≥3 occurring despite appropriate medical management and GR4 laboratory abnormality/GR3 lasting ≥7 days --GR4 neutropenia or thrombocytopenia lasting ≥7 days and not explained by the presence of leukemia after hematopoietic reconstitution --Any clinically important toxicity of GR≥2 requiring treatment discontinuation or interruption ≥7 days. |
| Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Days 8, 15, 22, 29, 36, 43, then every 3 weeks, then every 3 months after 1 Year, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) | GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. WBC: GR1=\<LLN-3.0\*10\^9/L; GR2=\<3.0-2.0\*10\^9/L; GR3=\<2.0-1.0\*10\^9/L; GR4=\<1.0\*10\^9/L. ANC: GR1=\<LLN-1.5\*10\^9 /L; GR2=\<1.5-1.0\*10\^9/L; GR3=\<1.0-0.5\*10\^9/L; GR4=\<0.5\*10\^9/L. Hemoglobin: GR1=\<LLN-10.0g/dL; GR2=\<10.0-8.0g/dL; GR3=\<8.0-6.5g/dL; GR4=\<6.5g/dL. Platelets: GR1=\<LLN-75.0\*10\^9/L; GR2=\<75.0-50.0\*10\^9/L; GR3=\<50.0-25.0\*10\^9/L; GR4=\<25.0\*10\^9/L. |
| Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) | GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Low calcium: GR1=\<LLN-8.0 mg/dL, GR2=\<8.0-7.0 mg/dL, GR3=\<7.0-6.0 mg/dL, GR4=\<6.0 mg/dL; Low magnesium: GR1=\<LLN-1.2 mg/dL, GR2=\<1.2-0.9 mg/dL, GR3=\<0.9-0.7 mg/dL, GR4=\<0.7 mg/dL; Low phosphate: GR1=\<LLN - 2.5 mg/dL, GR2=\<2.5 - 2.0 mg/dL, GR3=\<2.0 - 1.0 mg/dL, GR4=\<1.0 mg/dL. |
| Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) | GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. AST and ALT: GR1=\>ULN-2.5\*ULN; GR2=\>2.5-5.0\*ULN; GR3=\>5.0-20.0\*ULN; GR4:\>20.0\*ULN. Total bilirubin:GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3-10\*ULN, GR4=\>10\*ULN. Creatinine: GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3.0-6.0\*ULN, GR4=\>6.0\*ULN. |
| Number of Participants With Major Cytogenetic Response (MCyR) at Any Time in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]) | Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated. MCyR: A cytogenetic response that is either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR: 0% Ph+ cells in metaphase in BM. PCyR: \>0% to 35% Ph+ cells in metaphase in BM. |
| Number of Participants With Major Cytogenetic Response (MCyR) in Stratum 1 (Ph+ CP-CML) Within First 12 and 24 Weeks | After completion of Week 12 and 24 (measured at Weeks 13 and 25) | Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated. MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: \>0% to 35% Ph+ cells in metaphase in BM. |
| Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Strata 1 and 2/3: At Weeks 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Weeks 4, 19, 25, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]) | Best CyR was assessed based on the percentages of Ph+ metaphases of ≥20 analyzed metaphases in BM sample. Participants with complete, partial, minor, minimal, or no CyR. Refer to Outcome Measure 7 for definitions of CCyR and PCyR. Minor CyR:\>35%-65% Ph+ cells in metaphase in BM. Minimal CyR:\>65%-95% Ph+ cells in metaphase in BM. No CyR:\>95%-100% Ph+ cells in metaphase in BM. Unable to determine:Participants without valid cytogenetic assessment (i.e., at least 1 metaphase observed and number of Ph+ metaphases smaller than total number of metaphases \[%Ph+ \<100%\]). |
| Percentage of Participants With Complete Cytogenetic Response (CCyR) or Major Cytogenetic Response (MCyR) at Recommended Phase II Dose | Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]) | Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated. MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: \>0% to 35% Ph+ cells in metaphase in BM. |
| Time to Major Cytogenetic Response (MCyR) in Responders: Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Strata 1 and 2/3: At Weeks 7, 13, 25, 37, then every 12 weeks; Stratum 2/3: Additionally at Weeks 4, 19, 31; until first MCyR (maximum participant time to first MCyR of 92 days). | Defined as time (in days) from the first dose of dasatinib until criteria were first met for MCyR. MCyR: A CyR that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: \>0% to 35% Ph+ cells in metaphase in BM. The Kaplan-Meier plot was used. A 2-sided, 95% confidence interval (CI) for the median was computed using the Brookmeyer and Crowley method. |
| Duration of Major Cytogenetic Response (MCyR) in Responders (Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML]) | From the date of first MCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 48.6 months) | Defined as the time (in months) from the first day that all criteria were met for MCyR until the date of progression (based on the Investigator's assessment) or death (for participants whose best responses were MCyR and CCyR respectively). MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: \>0% to 35% Ph+ cells in metaphase in BM. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method. |
| Duration of Complete Cytogenetic Response (CCyR) in Responders: Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML] | From the date of first CCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 45.1 months) | Defined as time (in months) from the first day that all criteria were met for CCyR until the date of progression (based on the Investigator's assessment) or death (for participants whose best response was CCyR). CCyR = 0% Ph+ metaphases of ≥ 20 analyzed metaphases in BM aspiration. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method. |
| Number of Participants With Major Hematologic Response (MaHR) at Any Time in Stratum 2/3 (Ph+ ALL or AP/BP-CML) and Stratum 4 (Ph- ALL/AML) | Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; at Week 10 (only stratum 4); then every 12 weeks upto 24 months; then once/year; EOT(Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) | Defined as participants having as best response complete hematologic response (CHR) or CHR with incomplete platelet recovery (CHRp). Criteria: CHR-WBC in Peripheral Blood (PB):≤ULN; Immature cells in PB:No blasts, promyelocytes, myelocytes, metamyelocytes; Platelet count (untransfused):≥100,000/mm\^3 and ≤450,000/mm\^3; ANC:≥ 1000/mm\^3; Blasts in BM:\<5%; Extra medullary disease:No extramedullary leukemia, including no hepato or splenomegaly (regardless of CNS involvement). CHRp-CHR except platelet count (untransfused) & ANC:20,000/mm\^3 ≤platelet \<100,000/mm\^3 & /or 500/mm\^3 ≤ANC ≤1000/mm\^3. |
| Number of Participants With Major Hematologic Response (MaHR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML) Within First 6 and 24 Weeks | After completion of Week 6 and 24 (measured at weeks 7 and 25) | Defined as participants having as best response a CHR or CHRp. Criteria: CHR-WBC in PB:≤ULN; Immature cells in PB:No blasts, promyelocytes, myelocytes, metamyelocytes; Platelet count (untransfused):≥100,000/mm\^3 and ≤450,000/mm\^3; ANC:≥ 1000/mm\^3; Blasts in BM:\<5%; Extra medullary disease:No extramedullary leukemia, including no hepato or splenomegaly (regardless of CNS involvement). CHRp-CHR except platelet count (untransfused) and ANC:20,000/mm\^3 ≤platelet \<100,000/mm\^3 and /or 500/mm\^3 ≤ANC ≤1000/mm\^3. |
| Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML) | Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]) | HR: Determined by complete blood count (CBC), differential, and platelet count (PLT). Criteria for complete hematologic response (CHR): WBC in PB: \<10,000/mm\^3; Immature cells in PB: No blasts or promyelocytes (myelocytes + metamyelocytes) \<5%; Basophils in PB: \<5%; Platelet count (untransfused): \<450,000/mm\^3; Extra medullary disease: No extramedullary leukemia, including no splenomegaly. Unconfirmed HR = All criteria met. Confirmed HR = Criteria for HR fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval. |
| Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks up to 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72]) | HR was determined by CBC, differential, and platelet count. Refer to outcome measure 15 for criteria for CHR and CHRp. Criteria for minor hematologic response (MiHR): CHRp except blasts in BM-≥5% and ≤15% blasts in BM. Unconfirmed HR = All criteria met. periph=peripheral. Confirmed HR = Criteria for HR fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval. |
| Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) | Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 10, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38]) | HR was determined by CBC, differential, and platelet count. Unable to determine = Participants without any valid hematologic assessments. |
| Time to Major Hematologic Response (MaHR): Stratum 2/3 (PH+ ALL or AP/BP-CML) | Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; until confirmed MaHR (maximum participant time to first MaHR of 44 days). | Defined as time (in days) from first dose of dasatinib until the first day MaHR criteria were met, provided they were confirmed later (after 28 days) with no concomitant use of anagrelide or hydroxyurea during this interval. MaHR: Defined as participants having as best response a CHR or CHRp. Refer to Outcome Measure 15 for criteria for CHR and CHRp. Estimated by the Kaplan-Meier method and a 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method. |
| Time to Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML) | Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; at Week 4, 19, 31 (only stratum 2/3); then every 12 weeks upto 24 months; then once/year; until criteria was first met for CHR (maximum participant time to first CHR of 65 days). | Time to CHR is the time (in days) from first dose of dasatinib until the first day CHR criteria were met, provided they were confirmed later after 28 days with no concomitant use of anagrelide or hydroxyurea during this interval. Refer to Outcome Measure 16 for criteria to CHR in Stratum 1 and to Outcome Measure 15 for criteria for CHR in Stratum 2/3. Estimated by the Kaplan-Meier method and a 2-sided 95% CI for median was computed using the Brookmeyer and Crowley method. |
| Duration of Major Hematologic Response (MaHR): Stratum 2/3 (Ph+ALL or AP/BP-CML) | From the date of first confirmed MaHR to date of progression, death, or last tumor assessment (maximum participant duration of response of 37 months). | Duration of MaHR is the time (in months) from the first day criteria were met for MaHR, provided they were confirmed later at least after 28 days with no concomitant use of anagrelide or hydroxyurea during this interval, until death or progression was first observed. MaHR: Defined as participants having as best response a CHR or CHRp. Refer to outcome measure 20 for criteria for CHR or CHRp. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method. |
| Duration of Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML) | From the date of first confirmed CHR to date of progression, death, or last tumor assessment (maximum participant duration of response of 50 months). | Duration of CHR is the time (in months) from the first day criteria were met for CHR, provided they were confirmed later (after 28 days) with no concomitant use of anagrelide or hydroxyurea during this interval until death or progression was first observed. Refer to Outcome Measure 20 for criteria for CHR (Stratum 1) and Outcome Measure 19 for CHR (Stratum 2/3). The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method. |
| Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 1 (Ph+ CP-CML) | Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]) | A participant was said to have a confirmed HR if all the criteria for HR were fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval. HR observed in stratum 1 was CHR. Refer to Outcome Measure 20 for criteria for CHR. The Clopper and Pearson method was used to compute 95% exact CIs. |
| Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 2/3 (Ph+ALL or AP/BP-CML) | Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72]) | A participant is said to have a confirmed HR if criteria for HR were fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval. Confirmed HR observed in stratum 2/3 was either CHR or MaHR or overall hematologic response (OHR). Refer to Outcome Measure 19 for criteria for CHR and MaHR. OHR is defined as MaHR or MiHR. MiHR=CHRp except blasts in BM (≥ 5% and ≤ 15% blasts in BM). The Clopper and Pearson method was used to compute 95% exact CIs. |
| Number of Participants With Molecular Responses in Stratum 1 (Ph+ CP-CML) | At baseline (within 3 weeks before initiation of study therapy), After hematologic response, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]) | Molecular response was calculated by measuring p210 variant of BCR-ABL transcripts in blood during treatment using quantitative polymerase chain reaction (qPCR) assay. Major molecular response (MMR): Ratio of the BCR-ABL to ABL \<10\^-3 or 0.1% on the international scale. Complete molecular response (CMR): Complete absence of BCR-ABL or the ratio is \<10\^-4.5 or 0.00316% on the international scale. Confirmed MMR or CMR = Criteria met again \>6 weeks. BCR-ABL=the fused gene found in participants with this type of CML. |
| Number of Participants With Major Molecular Response (MMR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML) | At baseline (within 3 weeks before initiation of study therapy), After hematologic response, EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72]) | Molecular response was calculated by measuring BCR-ABL transcripts in blood during treatment using qPCR assay. MMR: Ratio of the BCR-ABL to ABL \<10\^-3 or a ≥3 log reduction from baseline in participants with p190 variant; ratio of the BCR-ABL to ABL \<10\^-3 on the international scale in participants with p210 variant. BCR-ABL=the fused gene found in participants with this type of CML. |
| Progression Free Survival (PFS) | From the date of randomization to date of progression, death, last tumor assessment, or 5 years after EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) | Time in months from 1st first dose until progression (resistance or refractory disease) or death was first documented by investigator. Progressive disease: Resistant disease for which investigator may electively stop treatment or refractory disease requiring cessation of study treatment. The PFS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median PFS time was computed using the method of Brookmeyer and Crowley. |
| Overall Survival (OS) | From start of study therapy until death or 5 years after EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) | Defined as time in months from start of study therapy to death. The OS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median OS time was computed using the Brookmeyer and Crowley method. |
| Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group | During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration. |
| Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Age Group | During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma. |
| Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) by Age Group | During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Dose Normalized Cmax is the maximum observed concentration of drug substance in plasma normalized for different dasatinib dose levels. |
| Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Age Group | During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC\[0-T\] is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration, normalized by dasatinib dose level. |
| Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Age Group | During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time, normalized by dasatinib dose level. |
| Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma. |
| Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration. |
| Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-T) is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration. |
| Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(INF) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. |
| Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma. |
| Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma. |
| Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours). | PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration. |
| Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group | 4 hours after oral dose | Concentration of dasatinib in CSF was assessed only in participants who had lumbar puncture during the treatment. y=years |
| Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML | At baseline (within 3 weeks before initiation of study therapy) | BCR-ABL, also referred to as the Philadelphia chromosome, is formed from the fusion of the BCR gene on chromosome 22 with the ABL gene on chromosome 9. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | At baseline (within 1 week before initiation of study therapy) | GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Low calcium: GR1=\<LLN-8.0 mg/dL, GR2=\<8.0-7.0 mg/dL, GR3=\<7.0-6.0 mg/dL, GR4=\<6.0 mg/dL; Low magnesium: GR1=\<LLN-1.2 mg/dL, GR2=\<1.2-0.9 mg/dL, GR3=\<0.9-0.7 mg/dL, GR4=\<0.7 mg/dL; Low phosphate: GR1=\<LLN - 2.5 mg/dL, GR2=\<2.5 - 2.0 mg/dL, GR3=\<2.0 - 1.0 mg/dL, GR4=\<1.0 mg/dL. |
| Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | At baseline (within 1 week before initiation of study therapy) | GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Aspartate aminotransferase (AST) and alanine aminotransferase(ALT): GR1=\>ULN-2.5\*ULN; GR2=\>2.5-5.0\*ULN; GR3=\>5.0-20.0\*ULN; GR4=\>20.0\*ULN. Total bilirubin:GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3-10\*ULN, GR4=\>10\*ULN. Creatinine: GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3.0-6.0\*ULN, GR4=\>6.0\*ULN. ULN=upper limit of normal. |
| Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | At baseline (within 1 week before initiation of study therapy) | GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. White Blood Cell (WBC):GR1=\<LLN-3.0\*10\^9/L; GR2=\<3.0-2.0\*10\^9/L; GR3=\<2.0-1.0\*10\^9/L; GR4=\<1.0\*10\^9/L. Absolute Neutrophil Count (ANC): GR1=\<LLN-1.5\*10\^9 /L; GR2=\<1.5-1.0\*10\^9/L; GR3=\<1.0-0.5\*10\^9/L; GR4=\<0.5\*10\^9/L. Hemoglobin: GR1=\<LLN-10.0g/dL; GR2=\<10.0-8.0g/dL; GR3=\<8.0-6.5g/dL; GR4=\<6.5g/dL. Platelets: GR1=\<LLN-75.0\*10\^9/L; GR2=\<75.0-50.0\*10\^9/L; GR3=\<50.0-25.0\*10\^9/L; GR4=\<25.0\*10\^9/L. LLN=lower limit of normal. |
Countries
Austria, France, Germany, Italy, Netherlands, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m\^2; Escalated/Dose Level 2 of 80 mg/m\^2. Once daily (QD), as long as clinical benefit was maintained. | 17 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2. QD, as long as clinical benefit was maintained. | 17 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2, Escalated/Dose level 3 of 100 mg/m\^2, and Escalated/Dose level 4 of 120 mg/m\^2. QD, as long as clinical benefit was maintained. | 24 |
| Total | 58 |
Baseline characteristics
| Characteristic | Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Total |
|---|---|---|---|---|
| Age, Continuous | 12.4 years STANDARD_DEVIATION 4.1 | 9.7 years STANDARD_DEVIATION 4.3 | 8.6 years STANDARD_DEVIATION 5.6 | 10.0 years STANDARD_DEVIATION 5 |
| Age, Customized > 18 years | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Customized < 2 years | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Age, Customized Between 12 and 18 years | 9 Participants | 7 Participants | 7 Participants | 23 Participants |
| Age, Customized Between 2 and 6 years | 2 Participants | 5 Participants | 7 Participants | 14 Participants |
| Age, Customized Between 7 and 11 years | 6 Participants | 5 Participants | 7 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 17 Participants | 16 Participants | 24 Participants | 57 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Black/African American | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 16 Participants | 15 Participants | 21 Participants | 52 Participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 8 Participants | 19 Participants |
| Sex: Female, Male Male | 11 Participants | 12 Participants | 16 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 16 / 17 | 16 / 17 | 24 / 24 |
| serious Total, serious adverse events | 8 / 17 | 14 / 17 | 22 / 24 |
Outcome results
Primary
Recommended Phase II Dose of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia
The recommended phase 2 dasatinib dose was determined based on efficacy, safety, and pharmacokinetic data obtained at the prespecified dose levels.
Time frame: From the date of first dose to end-of-treatment (EOT) (Median duration of therapy in months: Stratum 1=24.11 [Range:2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])
Population: All treated participants: Participants who received at least 1 dose of study therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Recommended Phase II Dose of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia | 60 mg/m^2 QD |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Recommended Phase II Dose of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia | 80 mg/m^2 QD |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Recommended Phase II Dose of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia | NA mg/m^2 QD |
Secondary
Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)
Best CyR was assessed based on the percentages of Ph+ metaphases of ≥20 analyzed metaphases in BM sample. Participants with complete, partial, minor, minimal, or no CyR. Refer to Outcome Measure 7 for definitions of CCyR and PCyR. Minor CyR:\>35%-65% Ph+ cells in metaphase in BM. Minimal CyR:\>65%-95% Ph+ cells in metaphase in BM. No CyR:\>95%-100% Ph+ cells in metaphase in BM. Unable to determine:Participants without valid cytogenetic assessment (i.e., at least 1 metaphase observed and number of Ph+ metaphases smaller than total number of metaphases \[%Ph+ \<100%\]).
Time frame: Strata 1 and 2/3: At Weeks 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Weeks 4, 19, 25, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])
Population: All treated participants (strata 1 and 2/3): Participants who received at least 1 dose of study therapy. Stratum 2/3 dasatinib 80 mg/m\^2 dose cohort includes 1 participant as having a CCyR due to a data entry error that was fixed after database lock for this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | No Response (>95% - 100%) | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Minimal (>65% - 95%) | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Minor (>35% - 65%) | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Partial (>0% - 35%) | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Complete (0%) | 8 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Unable to determine | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Unable to determine | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Partial (>0% - 35%) | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | No Response (>95% - 100%) | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Minor (>35% - 65%) | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Minimal (>65% - 95%) | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Complete (0%) | 6 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Minimal (>65% - 95%) | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Minor (>35% - 65%) | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Partial (>0% - 35%) | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Unable to determine | 4 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Complete (0%) | 4 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | No Response (>95% - 100%) | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Complete (0%) | 8 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Unable to determine | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Minimal (>65% - 95%) | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Partial (>0% - 35%) | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | No Response (>95% - 100%) | 1 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Minor (>35% - 65%) | 0 participants |
Secondary
Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML)
HR: Determined by complete blood count (CBC), differential, and platelet count (PLT). Criteria for complete hematologic response (CHR): WBC in PB: \<10,000/mm\^3; Immature cells in PB: No blasts or promyelocytes (myelocytes + metamyelocytes) \<5%; Basophils in PB: \<5%; Platelet count (untransfused): \<450,000/mm\^3; Extra medullary disease: No extramedullary leukemia, including no splenomegaly. Unconfirmed HR = All criteria met. Confirmed HR = Criteria for HR fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval.
Time frame: Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])
Population: All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML) | Best Confirmed HR-No Response | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML) | Best Confirmed HR-Complete | 10 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML) | Best Unconfirmed Hematologic Response-Complete | 10 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML) | Best Unconfirmed Hematologic Response-No Response | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML) | Best Unconfirmed Hematologic Response-No Response | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML) | Best Unconfirmed Hematologic Response-Complete | 6 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML) | Best Confirmed HR-Complete | 6 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML) | Best Confirmed HR-No Response | 0 participants |
Secondary
Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML)
HR was determined by CBC, differential, and platelet count. Refer to outcome measure 15 for criteria for CHR and CHRp. Criteria for minor hematologic response (MiHR): CHRp except blasts in BM-≥5% and ≤15% blasts in BM. Unconfirmed HR = All criteria met. periph=peripheral. Confirmed HR = Criteria for HR fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval.
Time frame: Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks up to 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])
Population: All treated participants in Stratum 2/3: Participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Best Confirmed HR-Complete | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Best Confirmed HR-Complete except periph. recovery | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Best Confirmed HR-No Response | 6 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Best Unconfirmed HR-Complete | 3 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Best Unconfirmed HR-Minor | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Best Unconfirmed HR-No Response | 5 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Best Unconfirmed HR-Minor | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Best Confirmed HR-Complete | 5 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Best Unconfirmed HR-Complete | 7 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Best Confirmed HR-Complete except periph. recovery | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Best Unconfirmed HR-No Response | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Best Confirmed HR-No Response | 3 participants |
Secondary
Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML)
HR was determined by CBC, differential, and platelet count. Unable to determine = Participants without any valid hematologic assessments.
Time frame: Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 10, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38])
Population: All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) | Best Confirmed HR-No Response | 5 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) | Best Confirmed HR-Unable to Determine | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) | Best Unconfirmed HR-No Response | 5 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) | Best Unconfirmed HR-Unable to Determine | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) | Best Unconfirmed HR-Unable to Determine | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) | Best Unconfirmed HR-No Response | 6 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) | Best Confirmed HR-Unable to Determine | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) | Best Confirmed HR-No Response | 6 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) | Best Unconfirmed HR-No Response | 6 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) | Best Unconfirmed HR-Unable to Determine | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) | Best Confirmed HR-Unable to Determine | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) | Best Confirmed HR-No Response | 6 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) | Best Confirmed HR-Unable to Determine | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) | Best Confirmed HR-No Response | 6 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) | Best Unconfirmed HR-Unable to Determine | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) | Best Unconfirmed HR-No Response | 6 participants |
Secondary
Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group
Concentration of dasatinib in CSF was assessed only in participants who had lumbar puncture during the treatment. y=years
Time frame: 4 hours after oral dose
Population: All treated participants with CSF samples available. n=number of PK parameters included. Each participant could have more than 1 CSF profiles sampled, depending on the number of times the dose of dasatinib was escalated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group | Children (age>=2 & <12 y; n=3, n=9, n=3, n=1) | 1.1 ng/mL | Standard Deviation 0.2 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group | Total (Children + Adolescents;n=4; n=10; n=6; n=1) | 1.1 ng/mL | Standard Deviation 0.1 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group | Adolescents (age>=12 & <18 y; n=1; n=1; n=3; n=0) | 1.1 ng/mL | — |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group | Children (age>=2 & <12 y; n=3, n=9, n=3, n=1) | 1.5 ng/mL | Standard Deviation 0.6 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group | Total (Children + Adolescents;n=4; n=10; n=6; n=1) | 1.4 ng/mL | Standard Deviation 0.6 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group | Adolescents (age>=12 & <18 y; n=1; n=1; n=3; n=0) | 1.0 ng/mL | — |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group | Adolescents (age>=12 & <18 y; n=1; n=1; n=3; n=0) | 2.6 ng/mL | Standard Deviation 0.6 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group | Children (age>=2 & <12 y; n=3, n=9, n=3, n=1) | 1.7 ng/mL | Standard Deviation 0.4 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group | Total (Children + Adolescents;n=4; n=10; n=6; n=1) | 2.1 ng/mL | Standard Deviation 0.7 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group | Children (age>=2 & <12 y; n=3, n=9, n=3, n=1) | 3.8 ng/mL | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group | Total (Children + Adolescents;n=4; n=10; n=6; n=1) | 3.8 ng/mL | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group | Adolescents (age>=12 & <18 y; n=1; n=1; n=3; n=0) | NA ng/mL | — |
Secondary
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-T) is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.
Time frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).
Population: All treated participants with plasma samples available. n=number of PK parameters included. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA ng.h/mL | — |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Children (age>=2 & <12yr; n=7; n=12; n=5; n=6) | 8.8 ng.h/mL | Geometric Coefficient of Variation 50.4 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Total | 10.3 ng.h/mL | Geometric Coefficient of Variation 44.9 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Adolescents (age>=12 & <12yr; n=6; n=8; n=9; n=2) | 12.3 ng.h/mL | Geometric Coefficient of Variation 38.4 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=0; n=1) | NA ng.h/mL | — |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Adolescents (age>=12 & <12yr; n=6; n=8; n=9; n=2) | 13.5 ng.h/mL | Geometric Coefficient of Variation 54.4 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | 6.6 ng.h/mL | — |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Total | 14.7 ng.h/mL | Geometric Coefficient of Variation 141.1 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Children (age>=2 & <12yr; n=7; n=12; n=5; n=6) | 16.6 ng.h/mL | Geometric Coefficient of Variation 145.2 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=0; n=1) | NA ng.h/mL | — |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Adolescents (age>=12 & <12yr; n=6; n=8; n=9; n=2) | 20.0 ng.h/mL | Geometric Coefficient of Variation 112.3 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=0; n=1) | NA ng.h/mL | — |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Children (age>=2 & <12yr; n=7; n=12; n=5; n=6) | 25.4 ng.h/mL | Geometric Coefficient of Variation 71.1 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA ng.h/mL | — |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Total | 21.8 ng.h/mL | Geometric Coefficient of Variation 100.1 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA ng.h/mL | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Children (age>=2 & <12yr; n=7; n=12; n=5; n=6) | 23.6 ng.h/mL | Geometric Coefficient of Variation 102.2 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=0; n=1) | 1.9 ng.h/mL | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Adolescents (age>=12 & <12yr; n=6; n=8; n=9; n=2) | 15.8 ng.h/mL | Geometric Coefficient of Variation 105.5 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Total | 16.3 ng.h/mL | Geometric Coefficient of Variation 110.3 |
Secondary
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.
Time frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).
Population: All treated participants with plasma samples available. n=number of PK parameters included. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA ng/mL | — |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=16; n=7; n=7) | 3.6 ng/mL | Geometric Coefficient of Variation 46.4 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Total | 3.4 ng/mL | Geometric Coefficient of Variation 43.7 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Adolescents (age>=12 & <18yr; n=8; n=8; n=9; n=2) | 3.1 ng/mL | Geometric Coefficient of Variation 40.3 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=0; n=1) | NA ng/mL | — |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Adolescents (age>=12 & <18yr; n=8; n=8; n=9; n=2) | 3.6 ng/mL | Geometric Coefficient of Variation 56.7 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | 2.2 ng/mL | — |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Total | 3.4 ng/mL | Geometric Coefficient of Variation 74.4 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=16; n=7; n=7) | 3.4 ng/mL | Geometric Coefficient of Variation 82 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=0; n=1) | NA ng/mL | — |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Adolescents (age>=12 & <18yr; n=8; n=8; n=9; n=2) | 6.9 ng/mL | Geometric Coefficient of Variation 75 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=0; n=1) | NA ng/mL | — |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=16; n=7; n=7) | 6.0 ng/mL | Geometric Coefficient of Variation 69.3 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA ng/mL | — |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Total | 6.5 ng/mL | Geometric Coefficient of Variation 72 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA ng/mL | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=16; n=7; n=7) | 4.8 ng/mL | Geometric Coefficient of Variation 65.3 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=0; n=1) | 1.2 ng/mL | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Adolescents (age>=12 & <18yr; n=8; n=8; n=9; n=2) | 4.3 ng/mL | Geometric Coefficient of Variation 77.9 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Total | 4.1 ng/mL | Geometric Coefficient of Variation 70.8 |
Secondary
Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.
Time frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).
Population: All treated participants with plasma samples available. n=number of PK parameters included. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA hour |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=16; n=7; n=7) | 2.0 hour |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Total | 2.0 hour |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Adolescents (age>=12 & <18yr ; n=8; n=8; n=9; n=2) | 2.0 hour |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=0; n=1) | NA hour |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Adolescents (age>=12 & <18yr ; n=8; n=8; n=9; n=2) | 2.0 hour |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | 0.9 hour |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Total | 2.0 hour |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=16; n=7; n=7) | 2.0 hour |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=0; n=1) | NA hour |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Adolescents (age>=12 & <18yr ; n=8; n=8; n=9; n=2) | 2.0 hour |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=0; n=1) | NA hour |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=16; n=7; n=7) | 2.1 hour |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA hour |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Total | 2.0 hour |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA hour |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=16; n=7; n=7) | 2.0 hour |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=0; n=1) | 0.9 hour |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Adolescents (age>=12 & <18yr ; n=8; n=8; n=9; n=2) | 2.1 hour |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Total | 2.0 hour |
Secondary
Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-T) is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.
Time frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).
Population: All treated participants with plasma samples available. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated. n=number of PK parameters included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA ng.h/mL | — |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=16; n=8; n=6) | 295.0 ng.h/mL | Geometric Coefficient of Variation 63.5 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Total | 307.0 ng.h/mL | Geometric Coefficient of Variation 60.2 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Adolescents (age>=12 & <18yr; n=9; n=8; n=9; n=2) | 320.8 ng.h/mL | Geometric Coefficient of Variation 59.1 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1) | NA ng.h/mL | — |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Adolescents (age>=12 & <18yr; n=9; n=8; n=9; n=2) | 488.1 ng.h/mL | Geometric Coefficient of Variation 35 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | 367.2 ng.h/mL | — |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Total | 484.3 ng.h/mL | Geometric Coefficient of Variation 88.9 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=16; n=8; n=6) | 490.8 ng.h/mL | Geometric Coefficient of Variation 96.7 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1) | NA ng.h/mL | — |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Adolescents (age>=12 & <18yr; n=9; n=8; n=9; n=2) | 787.0 ng.h/mL | Geometric Coefficient of Variation 76.2 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1) | 100.8 ng.h/mL | — |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=16; n=8; n=6) | 373.5 ng.h/mL | Geometric Coefficient of Variation 82 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA ng.h/mL | — |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Total | 504.1 ng.h/mL | Geometric Coefficient of Variation 89.6 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA ng.h/mL | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=16; n=8; n=6) | 676.7 ng.h/mL | Geometric Coefficient of Variation 99.9 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1) | 134.9 ng.h/mL | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Adolescents (age>=12 & <18yr; n=9; n=8; n=9; n=2) | 526.1 ng.h/mL | Geometric Coefficient of Variation 56.6 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group | Total | 534.9 ng.h/mL | Geometric Coefficient of Variation 103.9 |
Secondary
Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(INF) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.
Time frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).
Population: All treated participants with plasma samples available. n=number of PK parameters included. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | 0 ng.h/mL | Geometric Coefficient of Variation 0 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=14; n=7; n=5) | 313.9 ng.h/mL | Geometric Coefficient of Variation 59.8 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Total | 310.3 ng.h/mL | Geometric Coefficient of Variation 58.6 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Adolescents (age>=12 & <18yr; n=8; n=5; n=7; n=2) | 305.8 ng.h/mL | Geometric Coefficient of Variation 60.9 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1) | 0 ng.h/mL | Geometric Coefficient of Variation 0 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Adolescents (age>=12 & <18yr; n=8; n=5; n=7; n=2) | 605.1 ng.h/mL | Geometric Coefficient of Variation 25.3 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | 390.0 ng.h/mL | — |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Total | 527.8 ng.h/mL | Geometric Coefficient of Variation 90.4 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=14; n=7; n=5) | 513.6 ng.h/mL | Geometric Coefficient of Variation 99.2 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1) | 0 ng.h/mL | Geometric Coefficient of Variation 0 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Adolescents (age>=12 & <18yr; n=8; n=5; n=7; n=2) | 1008.9 ng.h/mL | Geometric Coefficient of Variation 69.4 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1) | 127.7 ng.h/mL | — |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=14; n=7; n=5) | 429.1 ng.h/mL | Geometric Coefficient of Variation 76.8 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | 0 ng.h/mL | Geometric Coefficient of Variation 0 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Total | 589.8 ng.h/mL | Geometric Coefficient of Variation 86.2 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | 0 ng.h/mL | Geometric Coefficient of Variation 0 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=14; n=7; n=5) | 817.6 ng.h/mL | Geometric Coefficient of Variation 93.7 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1) | 142.1 ng.h/mL | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Adolescents (age>=12 & <18yr; n=8; n=5; n=7; n=2) | 547.8 ng.h/mL | Geometric Coefficient of Variation 58.2 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group | Total | 594.4 ng.h/mL | Geometric Coefficient of Variation 101.5 |
Secondary
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Age Group
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC\[0-T\] is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration, normalized by dasatinib dose level.
Time frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).
Population: All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated. n=number of PK parameters included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Age Group | Infants and Toddlers (age<2 years old; n=2) | 2.8 ng.h/mL/mg/m^2 | Geometric Coefficient of Variation 4.6 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Age Group | Children (age>=2 and <12 years old; n=40) | 6.1 ng.h/mL/mg/m^2 | Geometric Coefficient of Variation 95.7 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Age Group | Adolescents (age>=12 and <18 years old; n=28) | 3.8 ng.h/mL/mg/m^2 | Geometric Coefficient of Variation 66.8 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Age Group | Above 18 Years (n=1) | 2.2 ng.h/mL/mg/m^2 | — |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Age Group | Total (n=71) | 4.9 ng.h/mL/mg/m^2 | Geometric Coefficient of Variation 98.1 |
Secondary
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Age Group
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time, normalized by dasatinib dose level.
Time frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).
Population: All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated. n=number of PK parameters included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Age Group | Infants and Toddlers (age<2 years old; n=2) | 3.2 ng.h/mL/mg/m^2 | Geometric Coefficient of Variation 17.7 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Age Group | Children (age>=2 and <12 years old; n=36) | 6.7 ng.h/mL/mg/m^2 | Geometric Coefficient of Variation 95 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Age Group | Adolescents (age>=12 and <18 years old; n=22) | 4.2 ng.h/mL/mg/m^2 | Geometric Coefficient of Variation 67.6 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Age Group | Above 18 Years (n=1) | 2.4 ng.h/mL/mg/m^2 | — |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Age Group | Total (n=61) | 5.4 ng.h/mL/mg/m^2 | Geometric Coefficient of Variation 97.1 |
Secondary
Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) by Age Group
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Dose Normalized Cmax is the maximum observed concentration of drug substance in plasma normalized for different dasatinib dose levels.
Time frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).
Population: All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated. n=number of PK parameters included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) by Age Group | Infants and Toddlers (age<2 years old; n=2) | 1.0 ng/mL/mg/m^2 | Geometric Coefficient of Variation 15.2 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) by Age Group | Children (age>=2 and <12 years old; n=43) | 1.9 ng/mL/mg/m^2 | Geometric Coefficient of Variation 79.9 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) by Age Group | Adolescents (age>=12 and <18 years old; n=28) | 1.0 ng/mL/mg/m^2 | Geometric Coefficient of Variation 69.7 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) by Age Group | Above 18 Years (n=1) | 0.9 ng/mL/mg/m^2 | — |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) by Age Group | Total (n=74) | 1.5 ng/mL/mg/m^2 | Geometric Coefficient of Variation 86.9 |
Secondary
Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.
Time frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).
Population: All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated. n=number of PK parameters included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Adolescents (age>=12; n=9; n=8; n=9; n=2) | 92.6 ng/mL | Geometric Coefficient of Variation 50.6 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Infants and Toddlers (age>2yr; n=0; n=0; n=1; n=1) | NA ng/mL | — |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA ng/mL | — |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Children (age>=2 & <12yr; n=11; n=16; n=9; n=7) | 110.6 ng/mL | Geometric Coefficient of Variation 61.8 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Total | 102.1 ng/mL | Geometric Coefficient of Variation 58 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Adolescents (age>=12; n=9; n=8; n=9; n=2) | 116.5 ng/mL | Geometric Coefficient of Variation 73 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Children (age>=2 & <12yr; n=11; n=16; n=9; n=7) | 142.5 ng/mL | Geometric Coefficient of Variation 80.2 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | 143.2 ng/mL | — |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Infants and Toddlers (age>2yr; n=0; n=0; n=1; n=1) | NA ng/mL | — |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Total | 133.6 ng/mL | Geometric Coefficient of Variation 77.6 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Total | 148.1 ng/mL | Geometric Coefficient of Variation 75 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Infants and Toddlers (age>2yr; n=0; n=0; n=1; n=1) | 30.6 ng/mL | — |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Children (age>=2 & <12yr; n=11; n=16; n=9; n=7) | 111.2 ng/mL | Geometric Coefficient of Variation 82.6 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Adolescents (age>=12; n=9; n=8; n=9; n=2) | 235.1 ng/mL | Geometric Coefficient of Variation 59 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA ng/mL | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Total | 163.9 ng/mL | Geometric Coefficient of Variation 87.6 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA ng/mL | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Children (age>=2 & <12yr; n=11; n=16; n=9; n=7) | 208.4 ng/mL | Geometric Coefficient of Variation 78.5 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Infants and Toddlers (age>2yr; n=0; n=0; n=1; n=1) | 53.8 ng/mL | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group | Adolescents (age>=12; n=9; n=8; n=9; n=2) | 123.3 ng/mL | Geometric Coefficient of Variation 68.3 |
Secondary
Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Age Group
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.
Time frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).
Population: All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated. n=number of PK parameters included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Age Group | Adolescents (age>=12 and <18 years old; n=22) | 3.8 hours | Geometric Coefficient of Variation 43.9 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Age Group | Infants and Toddlers (age<2 years old; n=2) | 2.1 hours | Geometric Coefficient of Variation 24 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Age Group | Children (age>=2 and <12 years old; n=36) | 3.0 hours | Geometric Coefficient of Variation 62.8 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Age Group | Above 18 years (n=1) | 7.3 hours | — |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Age Group | Total (n=61) | 3.3 hours | Geometric Coefficient of Variation 55.7 |
Secondary
Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.
Time frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).
Population: All treated participants with plasma samples available. n=number of PK parameters included. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Adolescents (age>=12 & <18yr; n=8; n=5; n=7; n=2) | 3.7 hour | Standard Deviation 1.6 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=14; n=7; n=5) | 2.4 hour | Standard Deviation 1 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1) | NA hour | — |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Total | 3.0 hour | Standard Deviation 1.4 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA hour | — |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | 7.3 hour | — |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1) | NA hour | — |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=14; n=7; n=5) | 3.9 hour | Standard Deviation 1.9 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Adolescents (age>=12 & <18yr; n=8; n=5; n=7; n=2) | 5.1 hour | Standard Deviation 0.5 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Total | 4.4 hour | Standard Deviation 1.8 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Adolescents (age>=12 & <18yr; n=8; n=5; n=7; n=2) | 4.5 hour | Standard Deviation 2.5 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA hour | — |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Total | 4.4 hour | Standard Deviation 2.9 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=14; n=7; n=5) | 4.6 hour | Standard Deviation 3.5 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1) | 2.5 hour | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Children (age>=2 & <12yr; n=10; n=14; n=7; n=5) | 3.2 hour | Standard Deviation 1.9 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Adolescents (age>=12 & <18yr; n=8; n=5; n=7; n=2) | 3.5 hour | Standard Deviation 2.9 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA hour | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Total | 3.1 hour | Standard Deviation 1.9 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1) | 1.8 hour | — |
Secondary
Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.
Time frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).
Population: All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated. n=number of PK parameters included.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group | Infants and Toddlers (age<2 years old; n=2) | 0.5 hours | Full Range 0 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group | Children (age>=2 and <12 years old; n=43) | 1.1 hours | Full Range 58.6 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group | Adolescents (age>=12 and <18 years old; n=28) | 1.0 hours | Full Range 82.2 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group | Above 18 Years (n=1) | 0.9 hours | — |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group | Total (n=74) | 1.0 hours | Full Range 70.9 |
Secondary
Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.
Time frame: During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).
Population: All treated participants with plasma samples available. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated. n=number of PK parameters included.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA hour | — |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Children (age>=2 & <12yr; n=11; n=16; n=9; n=7) | 1.1 hour | Full Range 61.8 |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Total | 1.0 hour | — |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Adolescents (age>=12 & <12yr; n=9; n=8; n=9; n=2) | 1.0 hour | — |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1) | NA hour | — |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Adolescents (age>=12 & <12yr; n=9; n=8; n=9; n=2) | 1.1 hour | — |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | 0.9 hour | — |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Total | 1.1 hour | — |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Children (age>=2 & <12yr; n=11; n=16; n=9; n=7) | 1.5 hour | — |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1) | NA hour | — |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Adolescents (age>=12 & <12yr; n=9; n=8; n=9; n=2) | 1.0 hour | — |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1) | 0.5 hour | — |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Children (age>=2 & <12yr; n=11; n=16; n=9; n=7) | 1.1 hour | — |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA hour | — |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Total | 1.0 hour | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Above 18 years (n=0; n=1; n=0; n=0) | NA hour | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Children (age>=2 & <12yr; n=11; n=16; n=9; n=7) | 1.0 hour | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Infants and Toddlers (age<2yr; n=0; n=0; n=1; n=1) | 0.5 hour | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Adolescents (age>=12 & <12yr; n=9; n=8; n=9; n=2) | 1.6 hour | — |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group | Total | 1.0 hour | — |
Secondary
Duration of Complete Cytogenetic Response (CCyR) in Responders: Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML]
Defined as time (in months) from the first day that all criteria were met for CCyR until the date of progression (based on the Investigator's assessment) or death (for participants whose best response was CCyR). CCyR = 0% Ph+ metaphases of ≥ 20 analyzed metaphases in BM aspiration. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method.
Time frame: From the date of first CCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 45.1 months)
Population: All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed \& the number of Ph+ metaphases smaller than the total number of metaphases \[%Ph+ \<100%\]) were considered responders. Participants who neither progressed nor died were censored on the date of their last valid cytogenetic assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Duration of Complete Cytogenetic Response (CCyR) in Responders: Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML] | 48.1 months |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Duration of Complete Cytogenetic Response (CCyR) in Responders: Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML] | 4.6 months |
Secondary
Duration of Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML)
Duration of CHR is the time (in months) from the first day criteria were met for CHR, provided they were confirmed later (after 28 days) with no concomitant use of anagrelide or hydroxyurea during this interval until death or progression was first observed. Refer to Outcome Measure 20 for criteria for CHR (Stratum 1) and Outcome Measure 19 for CHR (Stratum 2/3). The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method.
Time frame: From the date of first confirmed CHR to date of progression, death, or last tumor assessment (maximum participant duration of response of 50 months).
Population: Treated participants with CHR in strata 1 and 2/3. Participants who neither discontinued due to progression nor progressed nor died were censored on the date of their last hematologic or cytogenetic assessment, whichever came last.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Duration of Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML) | NA months |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Duration of Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML) | 7.3 months |
Secondary
Duration of Major Cytogenetic Response (MCyR) in Responders (Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML])
Defined as the time (in months) from the first day that all criteria were met for MCyR until the date of progression (based on the Investigator's assessment) or death (for participants whose best responses were MCyR and CCyR respectively). MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: \>0% to 35% Ph+ cells in metaphase in BM. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method.
Time frame: From the date of first MCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 48.6 months)
Population: All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed \& the number of Ph+ metaphases smaller than the total number of metaphases \[%Ph+ \<100%\]) were considered responders. Participants who neither progressed nor died were censored on the date of their last valid cytogenetic assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Duration of Major Cytogenetic Response (MCyR) in Responders (Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML]) | 52.2 months |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Duration of Major Cytogenetic Response (MCyR) in Responders (Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML]) | 4.6 months |
Secondary
Duration of Major Hematologic Response (MaHR): Stratum 2/3 (Ph+ALL or AP/BP-CML)
Duration of MaHR is the time (in months) from the first day criteria were met for MaHR, provided they were confirmed later at least after 28 days with no concomitant use of anagrelide or hydroxyurea during this interval, until death or progression was first observed. MaHR: Defined as participants having as best response a CHR or CHRp. Refer to outcome measure 20 for criteria for CHR or CHRp. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method.
Time frame: From the date of first confirmed MaHR to date of progression, death, or last tumor assessment (maximum participant duration of response of 37 months).
Population: All treated participants with MaHR in stratum 2/3. Participants who neither discontinued due to progression nor progressed nor died were censored on the date of their last hematologic or cytogenetic assessment, whichever came last.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Duration of Major Hematologic Response (MaHR): Stratum 2/3 (Ph+ALL or AP/BP-CML) | 4.4 months |
Secondary
Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML
BCR-ABL, also referred to as the Philadelphia chromosome, is formed from the fusion of the BCR gene on chromosome 22 with the ABL gene on chromosome 9.
Time frame: At baseline (within 3 weeks before initiation of study therapy)
Population: All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML | T315I | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML | Y253F | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML | G250E | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML | No Mutation | 15 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML | Y253H | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML | No Data | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML | L384M | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML | No Data | 3 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML | L384M | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML | G250E | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML | T315I | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML | Y253H | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML | Y253F | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML | No Mutation | 11 participants |
Secondary
Number of Participants With BCR-ABL Mutations at End-of-Treatment: Stratum1 Ph+ CP-CML and Stratum2/3 Ph+ ALL or AP/BP-CML
BCR-ABL = These are fused genes found in participants with this type of leukemia.
Time frame: At EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])
Population: All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at End-of-Treatment: Stratum1 Ph+ CP-CML and Stratum2/3 Ph+ ALL or AP/BP-CML | No Data | 9 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at End-of-Treatment: Stratum1 Ph+ CP-CML and Stratum2/3 Ph+ ALL or AP/BP-CML | T315I | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at End-of-Treatment: Stratum1 Ph+ CP-CML and Stratum2/3 Ph+ ALL or AP/BP-CML | No Mutation | 8 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at End-of-Treatment: Stratum1 Ph+ CP-CML and Stratum2/3 Ph+ ALL or AP/BP-CML | No Data | 4 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at End-of-Treatment: Stratum1 Ph+ CP-CML and Stratum2/3 Ph+ ALL or AP/BP-CML | T315I | 4 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With BCR-ABL Mutations at End-of-Treatment: Stratum1 Ph+ CP-CML and Stratum2/3 Ph+ ALL or AP/BP-CML | No Mutation | 9 participants |
Secondary
Number of Participants With Dose-limiting Toxicity (DLT)
DLTs: AEs which were at least possibly drug-related occurring within first 3 weeks of dasatinib therapy (toxicities occurring after 21 days were also considered) and are:- --Any nonhematologic clinically-apparent toxicity of Grade(GR)≥3 occurring despite appropriate medical management and GR4 laboratory abnormality/GR3 lasting ≥7 days --GR4 neutropenia or thrombocytopenia lasting ≥7 days and not explained by the presence of leukemia after hematopoietic reconstitution --Any clinically important toxicity of GR≥2 requiring treatment discontinuation or interruption ≥7 days.
Time frame: From the date of first dose until at least 30 days after the last dose of study drug (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])
Population: All treated participants: Participants who received at least 1 dose of study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Dose-limiting Toxicity (DLT) | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Dose-limiting Toxicity (DLT) | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Dose-limiting Toxicity (DLT) | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Dose-limiting Toxicity (DLT) | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Dose-limiting Toxicity (DLT) | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Dose-limiting Toxicity (DLT) | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Dose-limiting Toxicity (DLT) | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Dose-limiting Toxicity (DLT) | 1 participants |
Secondary
Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline
FLT3 and KIT = These are fused genes found in participants with this type of leukemia.
Time frame: At baseline (within 3 weeks before initiation of study therapy)
Population: All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline | FLT3 Absent | 20 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline | FLT3 Present | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline | FLT3 No Data | 3 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline | KIT Absent | 21 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline | KIT Present | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline | KIT No Data | 3 participants |
Secondary
Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment
FLT3 and KIT = These are fused genes found in participants with this type of leukemia.
Time frame: At EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38])
Population: All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment | FLT3 Absent | 6 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment | FLT3 Present | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment | FLT3 No Data | 18 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment | KIT Absent | 6 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment | KIT Present | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment | KIT No Data | 18 participants |
Secondary
Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0
GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. WBC: GR1=\<LLN-3.0\*10\^9/L; GR2=\<3.0-2.0\*10\^9/L; GR3=\<2.0-1.0\*10\^9/L; GR4=\<1.0\*10\^9/L. ANC: GR1=\<LLN-1.5\*10\^9 /L; GR2=\<1.5-1.0\*10\^9/L; GR3=\<1.0-0.5\*10\^9/L; GR4=\<0.5\*10\^9/L. Hemoglobin: GR1=\<LLN-10.0g/dL; GR2=\<10.0-8.0g/dL; GR3=\<8.0-6.5g/dL; GR4=\<6.5g/dL. Platelets: GR1=\<LLN-75.0\*10\^9/L; GR2=\<75.0-50.0\*10\^9/L; GR3=\<50.0-25.0\*10\^9/L; GR4=\<25.0\*10\^9/L.
Time frame: Days 8, 15, 22, 29, 36, 43, then every 3 weeks, then every 3 months after 1 Year, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])
Population: All treated participants: Participants who received at least one dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR3 | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR3 | 2 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR2 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR1 | 4 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR2 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR2 | 4 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR1 | 3 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR2 | 4 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR1 | 3 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR1 | 6 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR3 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR3 | 2 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR4 | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR1 | 4 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR1 | 4 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR3 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR3 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR2 | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR1 | 3 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR2 | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR2 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR2 | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR1 | 4 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR1 | 1 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR3 | 2 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR1 | 1 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR3 | 1 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR2 | 3 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR2 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR1 | 2 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR4 | 1 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR4 | 3 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR1 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR4 | 1 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR2 | 2 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR2 | 5 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR3 | 4 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR4 | 4 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR3 | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR3 | 1 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR3 | 4 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR4 | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR3 | 1 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR1 | 1 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR4 | 3 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR1 | 1 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR2 | 2 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR3 | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR4 | 4 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR1 | 2 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR2 | 2 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR2 | 3 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR4 | 3 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR1 | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR2 | 3 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR2 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR3 | 3 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR2 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR4 | 4 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR1 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR4 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR2 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR4 | 4 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR2 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR3 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR4 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR2 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR4 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR4 | 5 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR2 | 3 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR2 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR2 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR3 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR3 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR3 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR4 | 4 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR1 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR4 | 6 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR2 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR2 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR2 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR4 | 3 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR3 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR3 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR4 | 5 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR2 | 3 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR3 | 3 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR2 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | WBC GR4 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR2 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR3 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | ANC GR4 | 3 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR2 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR3 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Platelet GR4 | 5 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR2 | 3 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Hemoglobin GR3 | 2 participants |
Secondary
Number of Participants With Major Cytogenetic Response (MCyR) at Any Time in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)
Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated. MCyR: A cytogenetic response that is either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR: 0% Ph+ cells in metaphase in BM. PCyR: \>0% to 35% Ph+ cells in metaphase in BM.
Time frame: Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])
Population: All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Major Cytogenetic Response (MCyR) at Any Time in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | 9 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Major Cytogenetic Response (MCyR) at Any Time in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | 6 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Major Cytogenetic Response (MCyR) at Any Time in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | 4 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Major Cytogenetic Response (MCyR) at Any Time in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | 7 participants |
Secondary
Number of Participants With Major Cytogenetic Response (MCyR) in Stratum 1 (Ph+ CP-CML) Within First 12 and 24 Weeks
Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated. MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: \>0% to 35% Ph+ cells in metaphase in BM.
Time frame: After completion of Week 12 and 24 (measured at Weeks 13 and 25)
Population: All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Major Cytogenetic Response (MCyR) in Stratum 1 (Ph+ CP-CML) Within First 12 and 24 Weeks | MCyR within first 12 weeks | 6 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Major Cytogenetic Response (MCyR) in Stratum 1 (Ph+ CP-CML) Within First 12 and 24 Weeks | MCyR within first 24 weeks | 9 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Major Cytogenetic Response (MCyR) in Stratum 1 (Ph+ CP-CML) Within First 12 and 24 Weeks | MCyR within first 12 weeks | 2 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Major Cytogenetic Response (MCyR) in Stratum 1 (Ph+ CP-CML) Within First 12 and 24 Weeks | MCyR within first 24 weeks | 5 participants |
Secondary
Number of Participants With Major Hematologic Response (MaHR) at Any Time in Stratum 2/3 (Ph+ ALL or AP/BP-CML) and Stratum 4 (Ph- ALL/AML)
Defined as participants having as best response complete hematologic response (CHR) or CHR with incomplete platelet recovery (CHRp). Criteria: CHR-WBC in Peripheral Blood (PB):≤ULN; Immature cells in PB:No blasts, promyelocytes, myelocytes, metamyelocytes; Platelet count (untransfused):≥100,000/mm\^3 and ≤450,000/mm\^3; ANC:≥ 1000/mm\^3; Blasts in BM:\<5%; Extra medullary disease:No extramedullary leukemia, including no hepato or splenomegaly (regardless of CNS involvement). CHRp-CHR except platelet count (untransfused) & ANC:20,000/mm\^3 ≤platelet \<100,000/mm\^3 & /or 500/mm\^3 ≤ANC ≤1000/mm\^3.
Time frame: Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; at Week 10 (only stratum 4); then every 12 weeks upto 24 months; then once/year; EOT(Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])
Population: All treated participants in strata 2/3 and 4: Participants who received at least 1 dose of study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Major Hematologic Response (MaHR) at Any Time in Stratum 2/3 (Ph+ ALL or AP/BP-CML) and Stratum 4 (Ph- ALL/AML) | 2 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Major Hematologic Response (MaHR) at Any Time in Stratum 2/3 (Ph+ ALL or AP/BP-CML) and Stratum 4 (Ph- ALL/AML) | 6 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Major Hematologic Response (MaHR) at Any Time in Stratum 2/3 (Ph+ ALL or AP/BP-CML) and Stratum 4 (Ph- ALL/AML) | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Major Hematologic Response (MaHR) at Any Time in Stratum 2/3 (Ph+ ALL or AP/BP-CML) and Stratum 4 (Ph- ALL/AML) | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Major Hematologic Response (MaHR) at Any Time in Stratum 2/3 (Ph+ ALL or AP/BP-CML) and Stratum 4 (Ph- ALL/AML) | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Major Hematologic Response (MaHR) at Any Time in Stratum 2/3 (Ph+ ALL or AP/BP-CML) and Stratum 4 (Ph- ALL/AML) | 0 participants |
Secondary
Number of Participants With Major Hematologic Response (MaHR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML) Within First 6 and 24 Weeks
Defined as participants having as best response a CHR or CHRp. Criteria: CHR-WBC in PB:≤ULN; Immature cells in PB:No blasts, promyelocytes, myelocytes, metamyelocytes; Platelet count (untransfused):≥100,000/mm\^3 and ≤450,000/mm\^3; ANC:≥ 1000/mm\^3; Blasts in BM:\<5%; Extra medullary disease:No extramedullary leukemia, including no hepato or splenomegaly (regardless of CNS involvement). CHRp-CHR except platelet count (untransfused) and ANC:20,000/mm\^3 ≤platelet \<100,000/mm\^3 and /or 500/mm\^3 ≤ANC ≤1000/mm\^3.
Time frame: After completion of Week 6 and 24 (measured at weeks 7 and 25)
Population: All treated participants in Stratum 2/3: Participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Major Hematologic Response (MaHR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML) Within First 6 and 24 Weeks | MaHR within first 6 weeks | 2 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Major Hematologic Response (MaHR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML) Within First 6 and 24 Weeks | MaHR within first 24 weeks | 2 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Major Hematologic Response (MaHR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML) Within First 6 and 24 Weeks | MaHR within first 6 weeks | 5 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Major Hematologic Response (MaHR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML) Within First 6 and 24 Weeks | MaHR within first 24 weeks | 6 participants |
Secondary
Number of Participants With Major Molecular Response (MMR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML)
Molecular response was calculated by measuring BCR-ABL transcripts in blood during treatment using qPCR assay. MMR: Ratio of the BCR-ABL to ABL \<10\^-3 or a ≥3 log reduction from baseline in participants with p190 variant; ratio of the BCR-ABL to ABL \<10\^-3 on the international scale in participants with p210 variant. BCR-ABL=the fused gene found in participants with this type of CML.
Time frame: At baseline (within 3 weeks before initiation of study therapy), After hematologic response, EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])
Population: All treated participants (14 with p190 variant and 3 with p210 variant BCR-ABL transcripts) in stratum 2/3: Participants who received at least 1 dose of study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Major Molecular Response (MMR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML) | 2 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Major Molecular Response (MMR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML) | 6 participants |
Secondary
Number of Participants With Molecular Responses in Stratum 1 (Ph+ CP-CML)
Molecular response was calculated by measuring p210 variant of BCR-ABL transcripts in blood during treatment using quantitative polymerase chain reaction (qPCR) assay. Major molecular response (MMR): Ratio of the BCR-ABL to ABL \<10\^-3 or 0.1% on the international scale. Complete molecular response (CMR): Complete absence of BCR-ABL or the ratio is \<10\^-4.5 or 0.00316% on the international scale. Confirmed MMR or CMR = Criteria met again \>6 weeks. BCR-ABL=the fused gene found in participants with this type of CML.
Time frame: At baseline (within 3 weeks before initiation of study therapy), After hematologic response, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])
Population: All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Molecular Responses in Stratum 1 (Ph+ CP-CML) | CMR (Unconfirmed) | 3 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Molecular Responses in Stratum 1 (Ph+ CP-CML) | CMR (Confirmed) | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Molecular Responses in Stratum 1 (Ph+ CP-CML) | MMR (Overall) | 6 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Molecular Responses in Stratum 1 (Ph+ CP-CML) | MMR (Overall) | 2 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Molecular Responses in Stratum 1 (Ph+ CP-CML) | CMR (Unconfirmed) | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Molecular Responses in Stratum 1 (Ph+ CP-CML) | CMR (Confirmed) | 0 participants |
Secondary
Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0.
AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 3 = Severe; Grade 4 = Life-threatening or disabling.
Time frame: From the date of first dose until at least 30 days after the last dose of study drug (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])
Population: All treated participants: Participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related Deaths | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related SAEs | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related AEs Leading to Discontinuation | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Grade 3/4 AEs | 5 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Grade 3/4 AEs | 3 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related SAEs | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related Deaths | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related AEs Leading to Discontinuation | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related Deaths | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Grade 3/4 AEs | 4 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related SAEs | 2 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related AEs Leading to Discontinuation | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related Deaths | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related SAEs | 3 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related AEs Leading to Discontinuation | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Grade 3/4 AEs | 3 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Grade 3/4 AEs | 3 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related AEs Leading to Discontinuation | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related SAEs | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related Deaths | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Grade 3/4 AEs | 4 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related AEs Leading to Discontinuation | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related SAEs | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related Deaths | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Grade 3/4 AEs | 3 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related Deaths | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related AEs Leading to Discontinuation | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related SAEs | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related SAEs | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related AEs Leading to Discontinuation | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Grade 3/4 AEs | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | Drug-Related Deaths | 0 participants |
Secondary
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0
GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Low calcium: GR1=\<LLN-8.0 mg/dL, GR2=\<8.0-7.0 mg/dL, GR3=\<7.0-6.0 mg/dL, GR4=\<6.0 mg/dL; Low magnesium: GR1=\<LLN-1.2 mg/dL, GR2=\<1.2-0.9 mg/dL, GR3=\<0.9-0.7 mg/dL, GR4=\<0.7 mg/dL; Low phosphate: GR1=\<LLN - 2.5 mg/dL, GR2=\<2.5 - 2.0 mg/dL, GR3=\<2.0 - 1.0 mg/dL, GR4=\<1.0 mg/dL.
Time frame: Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])
Population: All treated participants: Participants who received at least one dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR1 | 3 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR2 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR2 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR1 | 2 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low magnesium GR1 | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR2 | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR3 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR2 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR3 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR3 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR1 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR2 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low magnesium GR1 | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR1 | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR2 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR4 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR2 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR1 | 2 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR3 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR3 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR4 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR3 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR2 | 1 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR4 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low magnesium GR1 | 5 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR2 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR1 | 2 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR2 | 1 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR4 | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR2 | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR2 | 1 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR3 | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low magnesium GR1 | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR4 | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR1 | 2 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR3 | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR1 | 2 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR4 | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR1 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR2 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low magnesium GR1 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR2 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR2 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR3 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR2 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR2 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low magnesium GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR2 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR1 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR2 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low magnesium GR1 | 4 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR1 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR2 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR3 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR2 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR3 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR1 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR1 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR2 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR3 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Phosphate GR2 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Magnesium GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low Calcium GR2 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Low magnesium GR1 | 1 participants |
Secondary
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0
GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. AST and ALT: GR1=\>ULN-2.5\*ULN; GR2=\>2.5-5.0\*ULN; GR3=\>5.0-20.0\*ULN; GR4:\>20.0\*ULN. Total bilirubin:GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3-10\*ULN, GR4=\>10\*ULN. Creatinine: GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3.0-6.0\*ULN, GR4=\>6.0\*ULN.
Time frame: Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])
Population: All treated participants: Participants who received at least one dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR1 | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR2 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR3 | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR2 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR2 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR1 | 2 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR1 | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR2 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR1 | 4 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR1 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR3 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR1 | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR3 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR3 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR2 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR1 | 3 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR2 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR3 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR1 | 4 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR2 | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR2 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR2 | 2 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR2 | 1 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR4 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR1 | 4 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR4 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR1 | 5 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR2 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR1 | 1 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR3 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR4 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR1 | 1 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR4 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR3 | 1 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR3 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR2 | 2 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR3 | 1 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR4 | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR4 | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR3 | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR3 | 2 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR1 | 3 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR1 | 2 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR2 | 1 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR3 | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR4 | 2 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR1 | 1 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR2 | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR3 | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR4 | 0 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR1 | 1 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR2 | 1 participants |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR2 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR3 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR2 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR3 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR2 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR1 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR1 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR2 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR2 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR2 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR1 | 4 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR2 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR1 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR1 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR2 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR3 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR3 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR2 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR2 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR1 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR2 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR1 | 3 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR1 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR2 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR2 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR2 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR1 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR2 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | AST GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR1 | 2 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR2 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR3 | 1 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High ALT GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Total Bilirubin GR4 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR1 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR2 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR3 | 0 participants |
| Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2) | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | High Serum Creatinine GR4 | 0 participants |
Secondary
Overall Survival (OS)
Defined as time in months from start of study therapy to death. The OS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median OS time was computed using the Brookmeyer and Crowley method.
Time frame: From start of study therapy until death or 5 years after EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])
Population: All treated participants: Participants who received at least 1 dose of study therapy. Participants lost to followup were censored on the last date the participant was known to be alive.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Overall Survival (OS) | NA months |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Overall Survival (OS) | 8.6 months |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Overall Survival (OS) | 3.0 months |
Secondary
Percentage of Participants With Complete Cytogenetic Response (CCyR) or Major Cytogenetic Response (MCyR) at Recommended Phase II Dose
Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated. MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: \>0% to 35% Ph+ cells in metaphase in BM.
Time frame: Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])
Population: All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Percentage of Participants With Complete Cytogenetic Response (CCyR) or Major Cytogenetic Response (MCyR) at Recommended Phase II Dose | CCyR | 72.7 percentage of participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Percentage of Participants With Complete Cytogenetic Response (CCyR) or Major Cytogenetic Response (MCyR) at Recommended Phase II Dose | MCyR | 81.8 percentage of participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Percentage of Participants With Complete Cytogenetic Response (CCyR) or Major Cytogenetic Response (MCyR) at Recommended Phase II Dose | CCyR | 88.9 percentage of participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Percentage of Participants With Complete Cytogenetic Response (CCyR) or Major Cytogenetic Response (MCyR) at Recommended Phase II Dose | MCyR | 88.9 percentage of participants |
Secondary
Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 1 (Ph+ CP-CML)
A participant was said to have a confirmed HR if all the criteria for HR were fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval. HR observed in stratum 1 was CHR. Refer to Outcome Measure 20 for criteria for CHR. The Clopper and Pearson method was used to compute 95% exact CIs.
Time frame: Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])
Population: All treated participants in stratum 1 who received at least 1 dose of dasatinib 60 mg/m\^2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 1 (Ph+ CP-CML) | 90.9 percentage of participants |
Secondary
Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 2/3 (Ph+ALL or AP/BP-CML)
A participant is said to have a confirmed HR if criteria for HR were fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval. Confirmed HR observed in stratum 2/3 was either CHR or MaHR or overall hematologic response (OHR). Refer to Outcome Measure 19 for criteria for CHR and MaHR. OHR is defined as MaHR or MiHR. MiHR=CHRp except blasts in BM (≥ 5% and ≤ 15% blasts in BM). The Clopper and Pearson method was used to compute 95% exact CIs.
Time frame: Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])
Population: All treated participants in stratum 2/3: Participants who received at least 1 dose of dasatinib 80 mg/m\^2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 2/3 (Ph+ALL or AP/BP-CML) | CHR | 55.6 percentage of participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 2/3 (Ph+ALL or AP/BP-CML) | MaHR | 66.7 percentage of participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 2/3 (Ph+ALL or AP/BP-CML) | OHR | 66.7 percentage of participants |
Secondary
Progression Free Survival (PFS)
Time in months from 1st first dose until progression (resistance or refractory disease) or death was first documented by investigator. Progressive disease: Resistant disease for which investigator may electively stop treatment or refractory disease requiring cessation of study treatment. The PFS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median PFS time was computed using the method of Brookmeyer and Crowley.
Time frame: From the date of randomization to date of progression, death, last tumor assessment, or 5 years after EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])
Population: All treated participants: Participants who received at least 1 dose of study therapy. If no progression or death was reported, PFS was censored at the last assessment date done on-study (i.e., up to 30 days after last dosing date) at which non-progression was reported.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Progression Free Survival (PFS) | 53.6 months |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Progression Free Survival (PFS) | 4.9 months |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Progression Free Survival (PFS) | 1.4 months |
Secondary
Time to Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML)
Time to CHR is the time (in days) from first dose of dasatinib until the first day CHR criteria were met, provided they were confirmed later after 28 days with no concomitant use of anagrelide or hydroxyurea during this interval. Refer to Outcome Measure 16 for criteria to CHR in Stratum 1 and to Outcome Measure 15 for criteria for CHR in Stratum 2/3. Estimated by the Kaplan-Meier method and a 2-sided 95% CI for median was computed using the Brookmeyer and Crowley method.
Time frame: Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; at Week 4, 19, 31 (only stratum 2/3); then every 12 weeks upto 24 months; then once/year; until criteria was first met for CHR (maximum participant time to first CHR of 65 days).
Population: All treated participants with CHR in strata 1 and 2/3.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Time to Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML) | 21.5 days |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Time to Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML) | 39.5 days |
Secondary
Time to Major Cytogenetic Response (MCyR) in Responders: Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)
Defined as time (in days) from the first dose of dasatinib until criteria were first met for MCyR. MCyR: A CyR that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: \>0% to 35% Ph+ cells in metaphase in BM. The Kaplan-Meier plot was used. A 2-sided, 95% confidence interval (CI) for the median was computed using the Brookmeyer and Crowley method.
Time frame: Strata 1 and 2/3: At Weeks 7, 13, 25, 37, then every 12 weeks; Stratum 2/3: Additionally at Weeks 4, 19, 31; until first MCyR (maximum participant time to first MCyR of 92 days).
Population: All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed \& the number of Ph+ metaphases smaller than the total number of metaphases \[%Ph+ \<100%\]) were considered responders.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Time to Major Cytogenetic Response (MCyR) in Responders: Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | 75.0 days |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Time to Major Cytogenetic Response (MCyR) in Responders: Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | 33.5 days |
Secondary
Time to Major Hematologic Response (MaHR): Stratum 2/3 (PH+ ALL or AP/BP-CML)
Defined as time (in days) from first dose of dasatinib until the first day MaHR criteria were met, provided they were confirmed later (after 28 days) with no concomitant use of anagrelide or hydroxyurea during this interval. MaHR: Defined as participants having as best response a CHR or CHRp. Refer to Outcome Measure 15 for criteria for CHR and CHRp. Estimated by the Kaplan-Meier method and a 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method.
Time frame: Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; until confirmed MaHR (maximum participant time to first MaHR of 44 days).
Population: Treated participants with MaHR in stratum 2/3.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Time to Major Hematologic Response (MaHR): Stratum 2/3 (PH+ ALL or AP/BP-CML) | 36.0 days |
Other Pre-specified
Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0
GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. White Blood Cell (WBC):GR1=\<LLN-3.0\*10\^9/L; GR2=\<3.0-2.0\*10\^9/L; GR3=\<2.0-1.0\*10\^9/L; GR4=\<1.0\*10\^9/L. Absolute Neutrophil Count (ANC): GR1=\<LLN-1.5\*10\^9 /L; GR2=\<1.5-1.0\*10\^9/L; GR3=\<1.0-0.5\*10\^9/L; GR4=\<0.5\*10\^9/L. Hemoglobin: GR1=\<LLN-10.0g/dL; GR2=\<10.0-8.0g/dL; GR3=\<8.0-6.5g/dL; GR4=\<6.5g/dL. Platelets: GR1=\<LLN-75.0\*10\^9/L; GR2=\<75.0-50.0\*10\^9/L; GR3=\<50.0-25.0\*10\^9/L; GR4=\<25.0\*10\^9/L. LLN=lower limit of normal.
Time frame: At baseline (within 1 week before initiation of study therapy)
Population: All treated participants: Participants who received at least one dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | ANC GR1 | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | WBC GR2 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | WBC GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | WBC GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | WBC GR1 | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | ANC GR2 | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | ANC GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | ANC GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Platelet GR1 | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Platelet GR2 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Platelet GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Platelet GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Hemoglobin GR1 | 7 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Hemoglobin GR2 | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Hemoglobin GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Hemoglobin GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | ANC GR2 | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | ANC GR3 | 2 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | ANC GR4 | 2 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Hemoglobin GR2 | 7 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Platelet GR1 | 5 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Platelet GR2 | 2 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Hemoglobin GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Platelet GR3 | 3 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | WBC GR1 | 2 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Hemoglobin GR3 | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | WBC GR2 | 2 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Platelet GR4 | 2 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | WBC GR3 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | WBC GR4 | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | ANC GR1 | 2 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Hemoglobin GR1 | 7 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Platelet GR3 | 8 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | ANC GR2 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Hemoglobin GR1 | 7 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | WBC GR3 | 6 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | ANC GR3 | 3 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Hemoglobin GR4 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | WBC GR1 | 3 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | ANC GR4 | 13 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Platelet GR4 | 6 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | ANC GR1 | 3 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Platelet GR1 | 5 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Hemoglobin GR2 | 7 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | WBC GR2 | 2 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Platelet GR2 | 3 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | WBC GR4 | 4 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0 | Hemoglobin GR3 | 3 participants |
Other Pre-specified
Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0
GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Low calcium: GR1=\<LLN-8.0 mg/dL, GR2=\<8.0-7.0 mg/dL, GR3=\<7.0-6.0 mg/dL, GR4=\<6.0 mg/dL; Low magnesium: GR1=\<LLN-1.2 mg/dL, GR2=\<1.2-0.9 mg/dL, GR3=\<0.9-0.7 mg/dL, GR4=\<0.7 mg/dL; Low phosphate: GR1=\<LLN - 2.5 mg/dL, GR2=\<2.5 - 2.0 mg/dL, GR3=\<2.0 - 1.0 mg/dL, GR4=\<1.0 mg/dL.
Time frame: At baseline (within 1 week before initiation of study therapy)
Population: All treated participants: Participants who received at least one dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Calcium GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Magnesium GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Magnesium GR Not Reported | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Calcium GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Magnesium GR2 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Magnesium GR1 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Calcium GR Not Reported | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Phosphate GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Magnesium GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Calcium GR1 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Phosphate GR Not Reported | 2 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Phosphate GR2 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Calcium GR2 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Phosphate GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Phosphate GR1 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Phosphate GR2 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Magnesium GR2 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Magnesium GR3 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Calcium GR1 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Calcium GR2 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Calcium GR3 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Calcium GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Calcium GR Not Reported | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Magnesium GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Magnesium GR Not Reported | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Phosphate GR1 | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Magnesium GR1 | 6 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Phosphate GR3 | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Phosphate GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Phosphate GR Not Reported | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Calcium GR2 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Phosphate GR Not Reported | 2 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Phosphate GR1 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Calcium GR1 | 1 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Phosphate GR4 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Phosphate GR2 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Magnesium GR3 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Magnesium GR1 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Calcium GR Not Reported | 2 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Calcium GR4 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Phosphate GR3 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Magnesium GR4 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Calcium GR3 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Magnesium GR2 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0 | Low Magnesium GR Not Reported | 2 participants |
Other Pre-specified
Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0
GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Aspartate aminotransferase (AST) and alanine aminotransferase(ALT): GR1=\>ULN-2.5\*ULN; GR2=\>2.5-5.0\*ULN; GR3=\>5.0-20.0\*ULN; GR4=\>20.0\*ULN. Total bilirubin:GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3-10\*ULN, GR4=\>10\*ULN. Creatinine: GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3.0-6.0\*ULN, GR4=\>6.0\*ULN. ULN=upper limit of normal.
Time frame: At baseline (within 1 week before initiation of study therapy)
Population: All treated participants: Participants who received at least one dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Total Bilirubin GR Not Reported | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High ALT GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | AST GR1 | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Total Bilirubin G4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High ALT GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | AST GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Total Bilirubin GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High ALT GR Not Reported | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Serum Creatinine GR Not Reported | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Total Bilirubin GR2 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Total Bilirubin GR1 | 3 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Serum Creatinine GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | AST GR Not Reported | 1 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Serum Creatinine GR4 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Serum Creatinine GR2 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High ALT GR1 | 2 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | AST GR3 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Serum Creatinine GR1 | 2 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High ALT GR2 | 0 participants |
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | AST GR2 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Serum Creatinine GR3 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | AST GR1 | 3 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | AST GR2 | 2 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | AST GR3 | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | AST GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | AST GR Not Reported | 3 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High ALT GR1 | 6 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High ALT GR2 | 2 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High ALT GR3 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High ALT GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High ALT GR Not Reported | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Total Bilirubin GR1 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Total Bilirubin GR2 | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Total Bilirubin GR3 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Total Bilirubin G4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Total Bilirubin GR Not Reported | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Serum Creatinine GR1 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Serum Creatinine GR2 | 1 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Serum Creatinine GR4 | 0 participants |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Serum Creatinine GR Not Reported | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | AST GR2 | 1 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Total Bilirubin G4 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High ALT GR2 | 5 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Serum Creatinine GR Not Reported | 1 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Total Bilirubin GR Not Reported | 1 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High ALT GR1 | 6 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Serum Creatinine GR4 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Serum Creatinine GR1 | 4 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | AST GR Not Reported | 2 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | AST GR1 | 8 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Serum Creatinine GR2 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | AST GR4 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Total Bilirubin GR1 | 1 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High ALT GR Not Reported | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | AST GR3 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Total Bilirubin GR2 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High ALT GR4 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Serum Creatinine GR3 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High Total Bilirubin GR3 | 0 participants |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0 | High ALT GR3 | 0 participants |