Chronic Myeloid Leukemia
Conditions
Brief summary
The purpose of this study is to find a dose of Nivolumab that can be safely added to Dasatinib in patients with Chronic Myeloid Leukemia.
Interventions
DRUGDasatinib
DRUGNivolumab
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Confirmed diagnosis of Chronic Myeloid Leukemia in Chronic Phase or Accelerated Phase : * With historically documented Ph+ cells * ≥2 prior Tyrosine Kinase Inhibitors (TKI) therapies for CML * Currently progressing, resistance to or with a suboptimal response to their most recent therapy * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score 0 - 1
Exclusion criteria
* Blast phase CML * Known Abl-kinase mutation resistant to Dasatinib (e.g. T315I or T315A)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Laboratory Abnormalities in Specific Thyroid Tests | Up to 40 Months | Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN) |
| Incidence of Dose Limiting Toxicities (DLT) | Week 3 to week 6 | DLT will be determined based on the incidence and intensity of drug related adverse events (AEs). The following drug-related AEs (whether related to one or both agents) occurring during the first 6 weeks of combined treatment with both dasatinib plus nivolumab (ie, Weeks 3 to 8, inclusive) would be considered DLTs: * Grade 4 hematologic AE lasting \> 7 days despite appropriate medical intervention, except as noted below; * Grade 3 or Grade 4 nonhematologic AE irrespective of duration; * Grade 2 nonhematologic AE lasting \> 7 days despite appropriate medical intervention (exception: asymptomatic laboratory values of Grade 2 which do not require medical intervention); * Any toxicity managed by discontinuation of nivolumab; * Grade ≥ 2 AE not controlled by medical intervention and requiring dasatinib treatment interruption for \> 28 consecutive days; * Grade ≥ 2 AE not controlled by medical intervention and requiring missing 2 consecutive doses of nivolumab. |
| Incidence of Adverse Events (AEs) | Initiation of study drug to discontinuation of nivolumab stop date + 100 days or discontinuation of dasatinib + 30 days | Any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. |
| Incidence of Serious Adverse Events (SAEs) | Initiation of study drug to within 100 days of discontinuation of nivolumab dosing and 30 days of dasatinib dosing | Any untoward medical occurrence that at any dose: results in death, is life threatening, requires in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a important medical event.Requires inpatient hospitalization or causes prolongation of existing hospitalization, results. |
| Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology | Up to 40 Months | The number of participants with a shift in laboratory test results from baseline to Grade 3-4 in hematology |
| Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | Up to 40 Months | The number of participants with an abnormal Liver function test. Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants | Up to 36 Months | measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants. |
| Time to Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants | Up to 36 Months | measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants. |
| Time to Major Molecular Response (MMR) - CML-AP Participants | Up to 36 Months | measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants. |
| Duration of Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants | Up to 36 Months | will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment |
| Duration of Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants | Up to 36 Months | will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment |
| Duration of Major Molecular Response (MMR) - CML-AP Participants | Up to 36 Months | will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment |
| Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | upto 36 Months | Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR). MMR is defined as ≥ 3-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.1% on the International Scale (IS). |
| Time to Molecular Response 4.5(MR4.5) - CML-CP Prior Dasatinib Participants | Up to 36 Months | measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants. |
| Time to Molecular Response 4.5(MR4.5) - CML-AP Participants | Up to 36 Months | measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants. |
| Duration of Molecular Response 4.5 (MR4.5) - CML-CP No Prior Dasatinib Participants | Up to 36 Months | will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment |
| Duration of Molecular Response 4.5 (MR4.5) - CML-CP Prior Dasatinib Participants | Up to 36 Months | will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment |
| Duration of Molecular Response 4.5 (MR4.5) - CML-AP Participants | Up to 36 Months | will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment |
| Time to Molecular Response 4.5(MR4.5) - CML-CP No Prior Dasatinib Participants | Up to 36 Months | measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants. |
| Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | upto 36 Months | Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR). MMR is defined as ≥ 3-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.1% on the International Scale (IS). |
| Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | upto 36 Months | Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR). MMR is defined as ≥ 3-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.1% on the International Scale (IS). |
| Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | upto 36 Months | Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR). A molecular response 4.5 (MR4.5) was defined as ≥ 4.5-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.00316% on the International Scale (IS). |
| Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | upto 36 Months | Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR). A molecular response 4.5 (MR4.5) was defined as ≥ 4.5-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.00316% on the International Scale (IS). |
| Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | upto 36 Months | Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR). A molecular response 4.5 (MR4.5) was defined as ≥ 4.5-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.00316% on the International Scale (IS). |
Countries
Australia, Canada, France, Germany, Italy, Spain, United States
Participant flow
Pre-assignment details
35 Participants enrolled; 31 participants randomized. Reasons not randomized: 1 participant withdrew consent, 3 participants no longer met the study criteria.
Participants by arm
| Arm | Count |
|---|---|
| Dasatinib Only dasatinib 100 mg QD(CP) or 140 mg QD (AP) | 2 |
| Dose Level 1 Nivolumab 1 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP) | 13 |
| Dose Level 2 Nivolumab 3 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP) | 16 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event unrelated to Drug | 0 | 2 | 1 |
| Overall Study | No Longer Meets Study Criteria | 1 | 0 | 0 |
| Overall Study | Participant requested to Discontinue | 0 | 1 | 1 |
| Overall Study | Proceeded to stem cell transplant | 0 | 0 | 1 |
| Overall Study | Study Drug Toxicity | 0 | 0 | 1 |
| Overall Study | Sub-Optimal Response to dasatinib | 1 | 0 | 0 |
| Overall Study | Treatment Failure | 0 | 7 | 6 |
Baseline characteristics
| Characteristic | Dasatinib Only | Dose Level 1 | Dose Level 2 | Total |
|---|---|---|---|---|
| Age, Continuous | 48.5 Years STANDARD_DEVIATION 13.4 | 61.2 Years STANDARD_DEVIATION 12.4 | 47.1 Years STANDARD_DEVIATION 13.6 | 53.1 Years STANDARD_DEVIATION 14.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 4 Participants | 8 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 9 Participants | 7 Participants | 18 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 11 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Female | 1 Participants | 7 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 1 Participants | 6 Participants | 11 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 2 / 13 | 0 / 16 |
| other Total, other adverse events | 1 / 2 | 13 / 13 | 16 / 16 |
| serious Total, serious adverse events | 0 / 2 | 7 / 13 | 8 / 16 |
Outcome results
Primary
Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests
The number of participants with an abnormal Liver function test. Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN)
Time frame: Up to 40 Months
Population: All Treated Participants with at least one treatment measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib Only | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | Total Bilirubin (Tbili) > 2xULN | 0 Participants |
| Dasatinib Only | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | ALT or AST > 3xULN | 0 Participants |
| Dasatinib Only | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | ALT or AST > 5xULN | 0 Participants |
| Dasatinib Only | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | ALT or AST > 10xULN | 0 Participants |
| Dasatinib Only | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | ALT or AST > 20xULN | 0 Participants |
| Dasatinib Only | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | ALT or AST > 3xULN w/ Tbili > 2xULN within 1 day | 0 Participants |
| Dasatinib Only | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | ALT or AST > 3xULN w/ Tbili > 2xULN within 30 days | 0 Participants |
| Dose Level 1 | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | ALT or AST > 20xULN | 0 Participants |
| Dose Level 1 | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | ALT or AST > 3xULN w/ Tbili > 2xULN within 30 days | 1 Participants |
| Dose Level 1 | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | ALT or AST > 3xULN | 1 Participants |
| Dose Level 1 | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | ALT or AST > 10xULN | 0 Participants |
| Dose Level 1 | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | ALT or AST > 3xULN w/ Tbili > 2xULN within 1 day | 1 Participants |
| Dose Level 1 | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | ALT or AST > 5xULN | 0 Participants |
| Dose Level 1 | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | Total Bilirubin (Tbili) > 2xULN | 1 Participants |
| Dose Level 2 | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | ALT or AST > 5xULN | 0 Participants |
| Dose Level 2 | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | ALT or AST > 10xULN | 0 Participants |
| Dose Level 2 | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | ALT or AST > 3xULN w/ Tbili > 2xULN within 30 days | 0 Participants |
| Dose Level 2 | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | ALT or AST > 20xULN | 0 Participants |
| Dose Level 2 | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | Total Bilirubin (Tbili) > 2xULN | 1 Participants |
| Dose Level 2 | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | ALT or AST > 3xULN | 1 Participants |
| Dose Level 2 | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | ALT or AST > 3xULN w/ Tbili > 2xULN within 1 day | 0 Participants |
Primary
Incidence of Adverse Events (AEs)
Any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Time frame: Initiation of study drug to discontinuation of nivolumab stop date + 100 days or discontinuation of dasatinib + 30 days
Population: All Treated Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib Only | Incidence of Adverse Events (AEs) | CML-CP, Prior dasatinib treatment | 1 Number of Adverse Events |
| Dose Level 1 | Incidence of Adverse Events (AEs) | CML-CP, Prior dasatinib treatment | 8 Number of Adverse Events |
| Dose Level 1 | Incidence of Adverse Events (AEs) | CML-CP, No Prior dasatinib treatment | 1 Number of Adverse Events |
| Dose Level 1 | Incidence of Adverse Events (AEs) | CML-AP participants | 4 Number of Adverse Events |
| Dose Level 2 | Incidence of Adverse Events (AEs) | CML-CP, Prior dasatinib treatment | 11 Number of Adverse Events |
| Dose Level 2 | Incidence of Adverse Events (AEs) | CML-CP, No Prior dasatinib treatment | 2 Number of Adverse Events |
| Dose Level 2 | Incidence of Adverse Events (AEs) | CML-AP participants | 3 Number of Adverse Events |
Primary
Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology
The number of participants with a shift in laboratory test results from baseline to Grade 3-4 in hematology
Time frame: Up to 40 Months
Population: All Treated Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib Only | Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology | Hemoglobin | 0 Participants |
| Dasatinib Only | Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology | Platelets | 0 Participants |
| Dasatinib Only | Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology | Absolute Neutrophil Count (ANC) | 0 Participants |
| Dasatinib Only | Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology | White Blood Cell (WBC) | 0 Participants |
| Dose Level 1 | Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology | White Blood Cell (WBC) | 1 Participants |
| Dose Level 1 | Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology | Hemoglobin | 2 Participants |
| Dose Level 1 | Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology | Absolute Neutrophil Count (ANC) | 5 Participants |
| Dose Level 1 | Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology | Platelets | 5 Participants |
| Dose Level 2 | Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology | White Blood Cell (WBC) | 3 Participants |
| Dose Level 2 | Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology | Platelets | 4 Participants |
| Dose Level 2 | Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology | Absolute Neutrophil Count (ANC) | 3 Participants |
| Dose Level 2 | Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology | Hemoglobin | 4 Participants |
Primary
Incidence of Dose Limiting Toxicities (DLT)
DLT will be determined based on the incidence and intensity of drug related adverse events (AEs). The following drug-related AEs (whether related to one or both agents) occurring during the first 6 weeks of combined treatment with both dasatinib plus nivolumab (ie, Weeks 3 to 8, inclusive) would be considered DLTs: * Grade 4 hematologic AE lasting \> 7 days despite appropriate medical intervention, except as noted below; * Grade 3 or Grade 4 nonhematologic AE irrespective of duration; * Grade 2 nonhematologic AE lasting \> 7 days despite appropriate medical intervention (exception: asymptomatic laboratory values of Grade 2 which do not require medical intervention); * Any toxicity managed by discontinuation of nivolumab; * Grade ≥ 2 AE not controlled by medical intervention and requiring dasatinib treatment interruption for \> 28 consecutive days; * Grade ≥ 2 AE not controlled by medical intervention and requiring missing 2 consecutive doses of nivolumab.
Time frame: Week 3 to week 6
Population: All Treated Participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dasatinib Only | Incidence of Dose Limiting Toxicities (DLT) | 0 Number of Incidence |
| Dose Level 1 | Incidence of Dose Limiting Toxicities (DLT) | 0 Number of Incidence |
| Dose Level 2 | Incidence of Dose Limiting Toxicities (DLT) | 0 Number of Incidence |
Primary
Incidence of Laboratory Abnormalities in Specific Thyroid Tests
Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN)
Time frame: Up to 40 Months
Population: All Treated Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib Only | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN: WITH TSH ≤ ULN AT BASELINE | 0 Number of Incidences |
| Dasatinib Only | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 0 Number of Incidences |
| Dasatinib Only | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > 2*ULN | 0 Number of Incidences |
| Dasatinib Only | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 0 Number of Incidences |
| Dasatinib Only | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > 2*ULN: WITH ALL OTHER FT3/FT4 TEST ≥ LLN | 0 Number of Incidences |
| Dasatinib Only | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > 2*ULN: WITH TSH <= ULN AT BASELINE | 0 Number of Incidences |
| Dasatinib Only | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN: WITH ALL OTHER FT3/FT4 TEST ≤ ULN | 0 Number of Incidences |
| Dasatinib Only | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > 2*ULN: WITH AT LEAST ONE FT3/FT4 TEST < LLN | 0 Number of Incidences |
| Dasatinib Only | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN: WITH AT LEAST ONE FT3/FT4 TEST < LLN | 0 Number of Incidences |
| Dasatinib Only | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > 2*ULN: WITH FT3/FT4 TEST MISSING | 0 Number of Incidences |
| Dasatinib Only | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN: WITH AT LEAST ONE FT3/FT4 TEST > ULN | 0 Number of Incidences |
| Dasatinib Only | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN: WITH ALL OTHER FT3/FT4 TEST ≥ LLN | 0 Number of Incidences |
| Dasatinib Only | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN: WITH FT3/FT4 TEST MISSING | 0 Number of Incidences |
| Dasatinib Only | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN: WITH TSH >= LLN AT BASELINE | 0 Number of Incidences |
| Dasatinib Only | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN: WITH FT3/FT4 TEST MISSING | 0 Number of Incidences |
| Dose Level 1 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN: WITH TSH >= LLN AT BASELINE | 3 Number of Incidences |
| Dose Level 1 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 4 Number of Incidences |
| Dose Level 1 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN: WITH TSH ≤ ULN AT BASELINE | 3 Number of Incidences |
| Dose Level 1 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN: WITH AT LEAST ONE FT3/FT4 TEST < LLN | 2 Number of Incidences |
| Dose Level 1 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN: WITH ALL OTHER FT3/FT4 TEST ≥ LLN | 1 Number of Incidences |
| Dose Level 1 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN: WITH FT3/FT4 TEST MISSING | 1 Number of Incidences |
| Dose Level 1 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > 2*ULN | 2 Number of Incidences |
| Dose Level 1 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > 2*ULN: WITH TSH <= ULN AT BASELINE | 1 Number of Incidences |
| Dose Level 1 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > 2*ULN: WITH AT LEAST ONE FT3/FT4 TEST < LLN | 2 Number of Incidences |
| Dose Level 1 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > 2*ULN: WITH ALL OTHER FT3/FT4 TEST ≥ LLN | 0 Number of Incidences |
| Dose Level 1 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > 2*ULN: WITH FT3/FT4 TEST MISSING | 0 Number of Incidences |
| Dose Level 1 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 3 Number of Incidences |
| Dose Level 1 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN: WITH AT LEAST ONE FT3/FT4 TEST > ULN | 0 Number of Incidences |
| Dose Level 1 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN: WITH ALL OTHER FT3/FT4 TEST ≤ ULN | 1 Number of Incidences |
| Dose Level 1 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN: WITH FT3/FT4 TEST MISSING | 2 Number of Incidences |
| Dose Level 2 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN: WITH FT3/FT4 TEST MISSING | 2 Number of Incidences |
| Dose Level 2 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN: WITH ALL OTHER FT3/FT4 TEST ≤ ULN | 0 Number of Incidences |
| Dose Level 2 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 1 Number of Incidences |
| Dose Level 2 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN: WITH ALL OTHER FT3/FT4 TEST ≥ LLN | 1 Number of Incidences |
| Dose Level 2 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > 2*ULN: WITH ALL OTHER FT3/FT4 TEST ≥ LLN | 0 Number of Incidences |
| Dose Level 2 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN: WITH TSH >= LLN AT BASELINE | 1 Number of Incidences |
| Dose Level 2 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN: WITH AT LEAST ONE FT3/FT4 TEST < LLN | 1 Number of Incidences |
| Dose Level 2 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 4 Number of Incidences |
| Dose Level 2 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > 2*ULN: WITH TSH <= ULN AT BASELINE | 0 Number of Incidences |
| Dose Level 2 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN: WITH AT LEAST ONE FT3/FT4 TEST > ULN | 1 Number of Incidences |
| Dose Level 2 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > 2*ULN: WITH AT LEAST ONE FT3/FT4 TEST < LLN | 1 Number of Incidences |
| Dose Level 2 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > 2*ULN | 1 Number of Incidences |
| Dose Level 2 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN: WITH TSH ≤ ULN AT BASELINE | 3 Number of Incidences |
| Dose Level 2 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN: WITH FT3/FT4 TEST MISSING | 0 Number of Incidences |
| Dose Level 2 | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | TSH > 2*ULN: WITH FT3/FT4 TEST MISSING | 0 Number of Incidences |
Primary
Incidence of Serious Adverse Events (SAEs)
Any untoward medical occurrence that at any dose: results in death, is life threatening, requires in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a important medical event.Requires inpatient hospitalization or causes prolongation of existing hospitalization, results.
Time frame: Initiation of study drug to within 100 days of discontinuation of nivolumab dosing and 30 days of dasatinib dosing
Population: All Treated Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib Only | Incidence of Serious Adverse Events (SAEs) | CML-CP, Prior dasatinib treatment | 0 Number of Adverse Events |
| Dose Level 1 | Incidence of Serious Adverse Events (SAEs) | CML-CP, Prior dasatinib treatment | 3 Number of Adverse Events |
| Dose Level 1 | Incidence of Serious Adverse Events (SAEs) | CML-CP, No Prior dasatinib treatment | 0 Number of Adverse Events |
| Dose Level 1 | Incidence of Serious Adverse Events (SAEs) | CML-AP participants | 4 Number of Adverse Events |
| Dose Level 2 | Incidence of Serious Adverse Events (SAEs) | CML-CP, Prior dasatinib treatment | 4 Number of Adverse Events |
| Dose Level 2 | Incidence of Serious Adverse Events (SAEs) | CML-CP, No Prior dasatinib treatment | 2 Number of Adverse Events |
| Dose Level 2 | Incidence of Serious Adverse Events (SAEs) | CML-AP participants | 2 Number of Adverse Events |
Secondary
Duration of Major Molecular Response (MMR) - CML-AP Participants
will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Time frame: Up to 36 Months
Population: CML-AP Participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose Level 2 | Duration of Major Molecular Response (MMR) - CML-AP Participants | NA Months |
Secondary
Duration of Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants
will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Time frame: Up to 36 Months
Population: CML-CP No Prior Dasatinib participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose Level 1 | Duration of Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants | NA Months |
Secondary
Duration of Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants
will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Time frame: Up to 36 Months
Population: CML-CP Prior Dasatinib Participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose Level 1 | Duration of Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants | NA Months |
| Dose Level 2 | Duration of Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants | NA Months |
Secondary
Duration of Molecular Response 4.5 (MR4.5) - CML-AP Participants
will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Time frame: Up to 36 Months
Population: CML-AP Participants
Secondary
Duration of Molecular Response 4.5 (MR4.5) - CML-CP No Prior Dasatinib Participants
will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Time frame: Up to 36 Months
Population: CML-CP No Prior Dasatinib Participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose Level 1 | Duration of Molecular Response 4.5 (MR4.5) - CML-CP No Prior Dasatinib Participants | NA Months |
Secondary
Duration of Molecular Response 4.5 (MR4.5) - CML-CP Prior Dasatinib Participants
will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Time frame: Up to 36 Months
Population: CML-CP Prior Dasatinib Participants
Secondary
Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR). MMR is defined as ≥ 3-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.1% on the International Scale (IS).
Time frame: upto 36 Months
Population: All treated Participants, CML-AP Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dose Level 1 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | MMR Rate by 6 Months | 0 Percentage |
| Dose Level 1 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | MMR Rate by 12 Months | 0 Percentage |
| Dose Level 1 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | MMR Rate by 24 Months | 0 Percentage |
| Dose Level 1 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | MMR Rate by 36 Months | 0 Percentage |
| Dose Level 2 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | MMR Rate by 36 Months | 66.7 Percentage |
| Dose Level 2 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | MMR Rate by 6 Months | 33.3 Percentage |
| Dose Level 2 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | MMR Rate by 24 Months | 66.7 Percentage |
| Dose Level 2 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | MMR Rate by 12 Months | 66.7 Percentage |
Secondary
Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR). MMR is defined as ≥ 3-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.1% on the International Scale (IS).
Time frame: upto 36 Months
Population: All treated Participants, CML-CP no prior Dasatinib participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dose Level 1 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | MMR Rate by 6 Months | 100 Percentage of Participants |
| Dose Level 1 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | MMR Rate by 12 Months | 100 Percentage of Participants |
| Dose Level 1 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | MMR Rate by 24 Months | 100 Percentage of Participants |
| Dose Level 1 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | MMR Rate by 36 Months | 100 Percentage of Participants |
| Dose Level 2 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | MMR Rate by 36 Months | 0 Percentage of Participants |
| Dose Level 2 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | MMR Rate by 6 Months | 0 Percentage of Participants |
| Dose Level 2 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | MMR Rate by 24 Months | 0 Percentage of Participants |
| Dose Level 2 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | MMR Rate by 12 Months | 0 Percentage of Participants |
Secondary
Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR). MMR is defined as ≥ 3-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.1% on the International Scale (IS).
Time frame: upto 36 Months
Population: All treated Participants, CML-CP prior Dasatinib participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib Only | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MMR Rate by 6 Months | 0 Percentage |
| Dasatinib Only | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MMR Rate by 12 Months | 0 Percentage |
| Dasatinib Only | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MMR Rate by 24 Months | 0 Percentage |
| Dasatinib Only | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MMR Rate by 36 Months | 0 Percentage |
| Dose Level 1 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MMR Rate by 36 Months | 25.0 Percentage |
| Dose Level 1 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MMR Rate by 6 Months | 25 Percentage |
| Dose Level 1 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MMR Rate by 24 Months | 25 Percentage |
| Dose Level 1 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MMR Rate by 12 Months | 25 Percentage |
| Dose Level 2 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MMR Rate by 36 Months | 45.5 Percentage |
| Dose Level 2 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MMR Rate by 12 Months | 27.3 Percentage |
| Dose Level 2 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MMR Rate by 24 Months | 36.4 Percentage |
| Dose Level 2 | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MMR Rate by 6 Months | 18.2 Percentage |
Secondary
Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR). A molecular response 4.5 (MR4.5) was defined as ≥ 4.5-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.00316% on the International Scale (IS).
Time frame: upto 36 Months
Population: All treated Participants, CML-AP Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dose Level 1 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | MR4.5 Rate by 6 Months | 0.0 Percentage |
| Dose Level 1 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | MR4.5 Rate by 12 Months | 0.0 Percentage |
| Dose Level 1 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | MR4.5 Rate by 24 Months | 0.0 Percentage |
| Dose Level 1 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | MR4.5 Rate by 36 Months | 0.0 Percentage |
| Dose Level 2 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | MR4.5 Rate by 36 Months | 0.0 Percentage |
| Dose Level 2 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | MR4.5 Rate by 6 Months | 0.0 Percentage |
| Dose Level 2 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | MR4.5 Rate by 24 Months | 0.0 Percentage |
| Dose Level 2 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | MR4.5 Rate by 12 Months | 0.0 Percentage |
Secondary
Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR). A molecular response 4.5 (MR4.5) was defined as ≥ 4.5-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.00316% on the International Scale (IS).
Time frame: upto 36 Months
Population: All treated Participants, CML-CP no prior Dasatinib participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dose Level 1 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | MR4.5 Rate by 6 Months | 0.0 Percentage |
| Dose Level 1 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | MR4.5 Rate by 12 Months | 0.0 Percentage |
| Dose Level 1 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | MR4.5 Rate by 24 Months | 0.0 Percentage |
| Dose Level 1 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | MR4.5 Rate by 36 Months | 100 Percentage |
| Dose Level 2 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | MR4.5 Rate by 36 Months | 0.0 Percentage |
| Dose Level 2 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | MR4.5 Rate by 6 Months | 0.0 Percentage |
| Dose Level 2 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | MR4.5 Rate by 24 Months | 0.0 Percentage |
| Dose Level 2 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | MR4.5 Rate by 12 Months | 0.0 Percentage |
Secondary
Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR). A molecular response 4.5 (MR4.5) was defined as ≥ 4.5-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.00316% on the International Scale (IS).
Time frame: upto 36 Months
Population: All treated Participants, CML-CP prior Dasatinib participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dasatinib Only | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MR4.5 Rate by 24 Months | 0 Percentage |
| Dasatinib Only | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MR4.5 Rate by 6 Months | 0 Percentage |
| Dasatinib Only | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MR4.5 Rate by 36 Months | 0 Percentage |
| Dasatinib Only | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MR4.5 Rate by 12 Months | 0 Percentage |
| Dose Level 1 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MR4.5 Rate by 24 Months | 0.0 Percentage |
| Dose Level 1 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MR4.5 Rate by 12 Months | 0.0 Percentage |
| Dose Level 1 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MR4.5 Rate by 6 Months | 0.0 Percentage |
| Dose Level 1 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MR4.5 Rate by 36 Months | 0.0 Percentage |
| Dose Level 2 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MR4.5 Rate by 12 Months | 0.0 Percentage |
| Dose Level 2 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MR4.5 Rate by 6 Months | 0.0 Percentage |
| Dose Level 2 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MR4.5 Rate by 36 Months | 0.0 Percentage |
| Dose Level 2 | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | MR4.5 Rate by 24 Months | 0.0 Percentage |
Secondary
Time to Major Molecular Response (MMR) - CML-AP Participants
measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Time frame: Up to 36 Months
Population: CML-AP Participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose Level 1 | Time to Major Molecular Response (MMR) - CML-AP Participants | NA Months |
| Dose Level 2 | Time to Major Molecular Response (MMR) - CML-AP Participants | 5.54 Months |
Secondary
Time to Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants
measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Time frame: Up to 36 Months
Population: CML-CP No Prior Dasatinib Subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose Level 1 | Time to Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants | 0.53 Months |
| Dose Level 2 | Time to Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants | NA Months |
Secondary
Time to Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants
measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Time frame: Up to 36 Months
Population: CML-CP Prior Dasatinib participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dasatinib Only | Time to Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants | NA Months |
| Dose Level 1 | Time to Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants | NA Months |
| Dose Level 2 | Time to Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants | 35.45 Months |
Secondary
Time to Molecular Response 4.5(MR4.5) - CML-AP Participants
measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Time frame: Up to 36 Months
Population: CML-AP Participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose Level 1 | Time to Molecular Response 4.5(MR4.5) - CML-AP Participants | NA Months |
| Dose Level 2 | Time to Molecular Response 4.5(MR4.5) - CML-AP Participants | NA Months |
Secondary
Time to Molecular Response 4.5(MR4.5) - CML-CP No Prior Dasatinib Participants
measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Time frame: Up to 36 Months
Population: CML-CP No Prior Dasatinib Participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose Level 1 | Time to Molecular Response 4.5(MR4.5) - CML-CP No Prior Dasatinib Participants | 35.25 Months |
| Dose Level 2 | Time to Molecular Response 4.5(MR4.5) - CML-CP No Prior Dasatinib Participants | NA Months |
Secondary
Time to Molecular Response 4.5(MR4.5) - CML-CP Prior Dasatinib Participants
measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Time frame: Up to 36 Months
Population: CML-CP Prior Dasatinib Participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dasatinib Only | Time to Molecular Response 4.5(MR4.5) - CML-CP Prior Dasatinib Participants | NA Months |
| Dose Level 1 | Time to Molecular Response 4.5(MR4.5) - CML-CP Prior Dasatinib Participants | NA Months |
| Dose Level 2 | Time to Molecular Response 4.5(MR4.5) - CML-CP Prior Dasatinib Participants | NA Months |