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S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia

S0919, A Phase II Study of Idarubicin and Ara-C in Combination With Pravastatin for Poor-Risk Acute Myelogenous Leukemia

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00840177
Enrollment
115
Registered
2009-02-10
Start date
2009-12-10
Completion date
2021-10-21
Last updated
2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22)

Brief summary

RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Pravastatin may also help idarubicin and cytarabine work better by making cancer cells more sensitive to the drugs. Giving idarubicin and cytarabine together with pravastatin may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together with pravastatin works in treating patients with relapsed acute myeloid leukemia (AML). ADDITIONAL BACKGROUND: S0919 was initially designed for patients with relapsed acute myeloid leukemia (AML), where the patient's preceding remission had lasted ≥ 3 months. The null response rate was 30%. The study closed to accrual on Nov 1, 2012 after meeting the defined criterion for a positive study; and the results are being submitted to the American Society of Clinical Oncology meeting. Based on the promising results from this trial, the trial has now been amended to evaluate this therapeutic regimen in poor-risk patients (patients with newly diagnosed acute myeloid leukemia (AML) arising out of myelodysplastic syndrome (MDS), primary refractory acute myeloid leukemia (AML), and relapsed acute myeloid leukemia (AML) with the patient's preceding remission lasting \< 6 months).

Detailed description

COHORTS: Cohort 1 (Initial cohort: Relapsed AML with previous remission ≥ 3 months), Cohort 2 (Poor-risk cohort: MDS transformed to AML), Cohort 3 (Poor-risk cohort: Refractory or relapsed AML with previous remission \< 6 months) OBJECTIVES: * To test whether the complete remission (CR) rate (including CR with incomplete recovery) in patients with relapsed acute myeloid leukemia (AML) treated with idarubicin and cytarabine in combination with pravastatin is sufficiently high to warrant a phase III investigation. * To estimate relapse-free survival and overall survival rates in these patients. * To estimate the frequency and severity of toxicities of this regimen in these patients. * To evaluate, in a preliminary manner, whether pre-study cytogenetic features correlate with response in these patients. OUTLINE: This is a multicenter study. * Induction therapy: Patients receive oral pravastatin once daily on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Patients achieving complete remission proceed to consolidation therapy. * Consolidation therapy: Beginning 30-60 days after the start of induction therapy, patients receive oral pravastatin once daily on days 1-6 and idarubicin IV over 10-15 minutes and cytarabine IV continuously on days 4 and 5. Treatment repeats approximately every 5 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 5 years.

Interventions

DRUGcytarabine

1.5 g/m2/day given by continuous IV on days 4-7

DRUGidarubicin

12 mg/m2/day given intravenously over 10-15 minutes on days 4-6

1,280 mg/day given orally on days 1-8

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
SWOG Cancer Research Network
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Cohort 1 (Initial cohort: Relapsed AML with previous remission \>/= 3 months) is permanently closed to accrual DISEASE CHARACTERISTICS * Patients must have a previous morphologically confirmed diagnosis of acute myeloid leukemia (AML). Note: This protocol uses the World Health Organization (WHO) diagnostic criteria for acute myeloid leukemia (AML) (see Section 4.1). Patients with acute promyelocytic leukemia (APL, FAB, M3) or blastic transformation of chronic myelogenous leukemia (CMML) are not eligible. * Patients must have received at least one prior chemotherapy regimen for their acute myeloid leukemia (AML) and they may have received any type of chemotherapy. They must have achieved complete remission (CR), lasting at least three months with their last induction regimen and they must have relapsed after the last regimen. Relapse must be documented by a bone marrow examination demonstrating \> 5% blasts in the bone marrow not attributable to another cause. Refractory patients and patients who have received autologous or allogeneic stem cell transplantation are not eligible. Administration of hydroxyurea to control high white blood cell (WBC) count prior to, during and after registration is permitted. * Patients must not have symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias. Either an echocardiogram or multiple-gated acquisition (MUGA) scan with an ejection fraction ≥ 45% must be obtained within 28 days prior to registration. (Either method for measuring cardiac function is acceptable, however, the same scan must be used throughout treatment and follow-up to monitor the patient for cardiac toxicity.) If patient has symptoms suggestive of ischemia or congestive heart failure after that cardiac evaluation was done, a repeat study must be obtained prior to registration. * Patients must have a serum creatinine \< 2.0 mg/dl within 14 days prior to registration. * Patients must have a total bilirubin ≤ 2.0 x Institutional Upper Limit of Normal (IULN) within 14 days prior to registration, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis and not to liver dysfunction. * Patients must have SGOT (AST) ≤ 3.0 x IULN and SGPT (ALT) ≤ 3.0 x IULN within 14 days prior to registration. Treatment may begin with SGOT/SGPT above those limits, if the abnormalities are thought to be due to the patient's leukemia. * Patients must have Zubrod performance status of 0-2 (see Section 10.8). * Patients must be ≥ 18 years of age. * Patients must not have clinical evidence of leptomeningeal disease (a spinal tap does not need to be performed). * Patients not known to be HIV+ must be tested for HIV infection (the human immunodeficiency virus) within 14 days prior to registration (see Section 2.0 for justification). Patients who are HIV+ may be eligible providing they meet all of the following additional criteria within 14 days prior to registration: 1. Patient must have no history of AIDS defining events. 2. CD4 cells ≥ 500/mm3. 3. Viral load of \< 50 copies HIV mRNA/mm3 if on cART or \< 25,000 copies HIV mRNA if not on cART. 4. No zidovudine or stavudine as part of cART. Patients who are HIV+ and do not meet all of these criteria will not be eligible for this study. * Patients with prior malignancy (other than AML) are eligible. However, the patient must be in remission from the prior malignancy and have completed all chemotherapy and radiotherapy at least 6 months prior to registration and all treatment related toxicities must have been resolved. NOTE: For patients with prior history of malignancy who have received anthracyclines or mediastinal/pericardial radiation in the past, the risk versus benefit of therapy should be weighed, particularly in the setting of receiving consolidation therapy. * Patients must not have a systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment). * Southwest Oncology Group patients must be registered on SWOG-9007 (Cytogenetic Studies in Leukemia Patients). Collection of pretreatment marrow specimens must be completed within 28 days prior to registration. Pretreatment specimens of bone marrow (or peripheral blood if the marrow aspirate is a dry tap) must be submitted to an approved Southwest Oncology Group Cytogenetics Laboratory for cytogenetics analysis. Note that protocol SWOG-9007 also requires submission of specimens at additional timepoints. * Southwest Oncology Group patients must be offered participation in S9910 (Leukemia Centralized Reference Laboratories and Tissue Repositories Ancillary). If consent is given, collection of pretreatment blood and/or marrow specimens must be completed within 28 days prior to registration. If the patient consents to participate in S9910, pretreatment specimens of marrow and/or peripheral blood must be submitted to the Southwest Oncology Group Myeloid Repository at the University of New Mexico for cellular and molecular studies. Note that protocol S9910 also requests submission of specimens at additional timepoints. * Women of reproductive potential must have a negative pregnancy test within 14 days prior to registration. Patients must not be pregnant or nursing because of the teratogenic potential of the drugs used in this study. Women/men of reproductive potential must have agreed to use an effective contraceptive method. * All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. * At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base. Cohort 2 (MDS transformed to AML) is permanently closed to accrual AND Cohort 3 (relapsed/refractory AML) is permanently closed to accrual DISEASE CHARACTERISTICS: * For patients registered to relapsed/refractory (Cohort 3), morphologically confirmed diagnosis of acute myeloid leukemia (AML) * Patient registered to the myelodysplastic syndrome (MDS) transformed to acute myeloid leukemia (AML) cohort (Cohort 2) patients must have a previous morphologically confirmed diagnosis of myelodysplastic syndrome/chronic myelomonocytic leukemia (MDS/CMML). Patients may have received previous non-intensive therapy (such as: azacitidine, decitabine, low-dose cytarabine, lenalidomide) given treatment of myelodysplastic syndrome/chronic myelomonocytic leukemia (MDS/CMML) (with up to 20% blasts). At time of registration, patient must have morphologically confirmed diagnosis of acute myeloid leukemia (AML). * Patients with acute promyelocytic leukemia (i.e., APL, FAB M3) or blastic transformation of chronic myelogenous leukemia are not eligible * Patients must not have received autologous or allogeneic stem cell transplant. * Patients in the relapsed/refractory acute myeloid leukemia (AML) cohort (Cohort 3) must: * Have received ≥ 1 prior chemotherapy regimen for acute myeloid leukemia (AML) * Any type of prior chemotherapy allowed * Administration of hydroxyurea to control high white blood cell (WBC) prior to, during, and after registration is permitted * Relapse must be documented by a bone marrow examination demonstrating \> 5% blasts in the bone marrow not attributable to another cause * Patient must not have received chemo within 14 days prior to registration * Primary refractory patients eligible if, on Day 14 of previous chemo regimen, they have significant residual disease. Patients who received only hypomethylating agent or low dose therapy for Induction are not considered primary refractory for this study and are not eligible. * Relapsed patients must have achieved a complete remission (CR) or CR with incomplete blood count recovery that lasted \< 6 months after the last induction regimen * No clinical evidence of leptomeningeal disease * Pretreatment (collected within 28 days of registration) cytogenetics must be performed on all patients. * Patients must have complete history and physical exam within 28 days prior to registration. PATIENT CHARACTERISTICS: * No symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias * Ejection fraction ≥ 45% by echocardiogram or MUGA scan within 28 days prior to registration (or within 14 days prior to registration if the patient has received anthracycline in the 28 day window) * Zubrod performance status 0-2 * Serum creatinine ≤ 2.0 times upper limit of normal (ULN) * Total bilirubin ≤ 2.0 times ULN (unless elevation is primarily due to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis AND not due to liver dysfunction) * AST and ALT ≤ 3.0 times ULN * Not pregnant or nursing and negative pregnancy test within 14 days prior to registration. Females of child-bearing potential must agree to use effective contraception * No HIV positivity unless the following criteria are met: * No history of AIDS-defining events * CD4 count ≥ 500/mm³ * Viral load \< 25,000 copies (\< 50 copies if on combination antiretroviral therapy) * Not receiving zidovudine or stavudine as part of combination antiretroviral therapy * No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as exhibiting ongoing signs/symptoms related to the infection with no improvement despite appropriate antibiotics or other treatment * Patients with prior malignancy (other than AML and MDS/CMML) eligible provided patient is in remission from that malignancy at least 6 months prior to registration. Except for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) treatment, all treatment related toxicities must have been resolved.

Design outcomes

Primary

MeasureTime frameDescription
Complete Remission (CR) Rate (Including CR With Incomplete Recovery)Up to 5 years after registrationParticipants who achieved morphological complete remission with or without incomplete blood count recovery. Per the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, morphologic complete remission requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL.

Secondary

MeasureTime frameDescription
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Up to 5 years post registrationNumber of patients with Grade 3-5 adverse events that were possibly, probably or definitely related to study drug are reported by given type of adverse event

Other

MeasureTime frameDescription
Correlation Between Pre-study Cytogenetic Features and Response5 years
Overall Survival (OS)OS assessed for up to 5 years, median OS reportedOS is calculated for all participants from the date of initial registration on study until death from any cause. Observations for participants last known to be alive were censored.
Relapse-free Survival (RFS)RFS assessed for up to 5 years, median RFS reportedRFS is calculated for participants who have achieved a complete response (CR) or CR with incomplete blood count recovery (CRi). RFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse. Per the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, morphologic complete remission requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL.

Countries

United States

Participant flow

Participants by arm

ArmCount
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting ≥ 3 months
36
Poor-risk Cohort: MDS Transformed to AML
Participants with acute myeloid leukemia (AML) who had a previous morphologically confirmed diagnosis of MDS/CMML and for which they may have received previous non-intensive therapy.
29
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting \< 6 months.
46
Total111

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyAdverse Event511
Overall StudyDeath455
Overall StudyDid not start treatment001
Overall StudyIneligible003
Overall Studynot protocol specified630
Overall StudyProgression/relapse200
Overall StudyRefusal unrelated to adverse events101

Baseline characteristics

CharacteristicInitial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthPoor-risk Cohort: MDS Transformed to AMLPoor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionTotal
Age, Continuous58.6 years64.9 years57.3 years60.7 years
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants0 Participants4 Participants9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
29 Participants28 Participants38 Participants95 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants1 Participants4 Participants7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants6 Participants6 Participants
Race (NIH/OMB)
Black or African American
3 Participants1 Participants2 Participants6 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants3 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants0 Participants2 Participants
Race (NIH/OMB)
White
30 Participants28 Participants35 Participants93 Participants
Sex: Female, Male
Female
19 Participants13 Participants22 Participants54 Participants
Sex: Female, Male
Male
17 Participants16 Participants24 Participants57 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
27 / 3620 / 2941 / 46
other
Total, other adverse events
34 / 3528 / 2945 / 46
serious
Total, serious adverse events
5 / 358 / 2910 / 46

Outcome results

Primary

Complete Remission (CR) Rate (Including CR With Incomplete Recovery)

Participants who achieved morphological complete remission with or without incomplete blood count recovery. Per the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, morphologic complete remission requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL.

Time frame: Up to 5 years after registration

Population: Eligible participants who started treatment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthComplete Remission (CR) Rate (Including CR With Incomplete Recovery)27 Participants
Poor-risk Cohort: MDS Transformed to AMLComplete Remission (CR) Rate (Including CR With Incomplete Recovery)14 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionComplete Remission (CR) Rate (Including CR With Incomplete Recovery)14 Participants
Secondary

Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0

Number of patients with Grade 3-5 adverse events that were possibly, probably or definitely related to study drug are reported by given type of adverse event

Time frame: Up to 5 years post registration

Population: Eligible patients who were assessed for adverse events

ArmMeasureGroupValue (NUMBER)
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0AST, SGOT0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Mucositis/stomatitis (functional/symp) - Oral cav1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hemorrhage, pulmonary/upper respiratory - Nose0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Renal failure0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Ulceration0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hemorrhage/Bleeding-Other (Specify)1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Carbon monoxide diffusion capacity (DL(co))1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Mucositis/stomatitis (clinical exam) - Pharynx0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hypertension1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Rash/desquamation0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Mucositis/stomatitis (clinical exam) - Oral cavity0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hypotension1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pulmonary/Upper Respiratory-Other (Specify)0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Mental status1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hypoxia1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Potassium, serum-low (hypokalemia)6 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Magnesium, serum-high (hypermagnesemia)0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Ileus, GI (functional obstruction of bowel)1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Cardiac General-Other (Specify)1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Lymphopenia6 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Blood4 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Typhlitis (cecal inflammation)0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Lipase1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Cardiac-ischemia/infarction0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Leukocytes (total WBC)16 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Kidney0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Alkaline phosphatase0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Left ventricular diastolic dysfunction2 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Lung5 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Colitis, infectious (e.g., Clostridium difficile)0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Infection-Other (Specify)1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Meninges0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0ALT, SGPT (serum glutamic pyruvic transaminase)0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Infection with unknown ANC - Small bowel NOS0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Sinus1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Potassium, serum-high (hyperkalemia)0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pulmonary hypertension1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Skin0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Conduction abnormality - Asystole1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Infection with unknown ANC - Sinus1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Small bowel1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Syncope (fainting)1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Infection with unknown ANC - Mucosa0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Stomach0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pleural effusion (non-malignant)0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Infection with unknown ANC - Lung (pneumonia)0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Infection with unknown ANC - Blood1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Confusion1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Alkalosis (metabolic or respiratory)0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Platelets17 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Constitutional Symptoms-Other (Specify)0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Vomiting2 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Phosphate, serum-low (hypophosphatemia)2 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Creatinine0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Sodium, serum-low (hyponatremia)1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pain - Peritoneum0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Anorexia1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Diarrhea3 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Acidosis (metabolic or respiratory)0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pain - Oral cavity0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Distention/bloating, abdominal0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Sodium, serum-high (hypernatremia)1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pain - Extremity-limb0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Dry mouth/salivary gland (xerostomia)0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Bilirubin (hyperbilirubinemia)2 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pain - Esophagus0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Dyspnea (shortness of breath)2 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Weight loss0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pain - Bone0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Edema: limb0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0SVT and nodal arrhythmia - Atrial flutter1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pain - Abdomen NOS1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Esophagitis1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Blood/Bone Marrow-Other (Specify)2 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Opportunistic inf associated w/gt=Gr 2 lymphopenia0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Fatigue (asthenia, lethargy, malaise)3 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Ulcer, GI - Duodenum0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Ocular/Visual-Other (Specify)1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Febrile neutropenia20 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0SVT and nodal arrhythmia - Atrial fibrillation1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Obstruction, GI - Small bowel NOS0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Glucose, serum-high (hyperglycemia)1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Bone marrow cellularity1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Neutrophils/granulocytes (ANC/AGC)14 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hemoglobin11 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Albumin, serum-low (hypoalbuminemia)1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Necrosis, GI - Small bowel NOS0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hemorrhage, GI - Duodenum0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Renal/Genitourinary-Other (Specify)0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Nausea2 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hemorrhage, GU - Vagina1 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Calcium, serum-low (hypocalcemia)2 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Musculoskeletal/Soft Tissue-Other (Specify)0 Participants
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Carbon monoxide diffusion capacity (DL(co))4 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0ALT, SGPT (serum glutamic pyruvic transaminase)2 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0AST, SGOT3 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Acidosis (metabolic or respiratory)1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Albumin, serum-low (hypoalbuminemia)3 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Alkaline phosphatase0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Alkalosis (metabolic or respiratory)1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Anorexia1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Bilirubin (hyperbilirubinemia)2 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Blood/Bone Marrow-Other (Specify)1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Bone marrow cellularity0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Calcium, serum-low (hypocalcemia)5 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Cardiac General-Other (Specify)0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Cardiac-ischemia/infarction1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Colitis, infectious (e.g., Clostridium difficile)1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Conduction abnormality - Asystole0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Confusion0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Constitutional Symptoms-Other (Specify)2 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Creatinine3 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pain - Bone0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Diarrhea4 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Distention/bloating, abdominal2 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Dry mouth/salivary gland (xerostomia)1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Dyspnea (shortness of breath)1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Edema: limb2 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Esophagitis0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Fatigue (asthenia, lethargy, malaise)2 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Febrile neutropenia18 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Glucose, serum-high (hyperglycemia)2 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hemoglobin14 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hemorrhage, GI - Duodenum1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hemorrhage, GU - Vagina0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hemorrhage, pulmonary/upper respiratory - Nose0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hemorrhage/Bleeding-Other (Specify)0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hypertension0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hypotension2 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hypoxia2 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Ileus, GI (functional obstruction of bowel)2 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Blood4 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Kidney0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Lung2 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Meninges0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Sinus0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Skin1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Small bowel0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Stomach0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Infection with unknown ANC - Blood2 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Infection with unknown ANC - Lung (pneumonia)1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Infection with unknown ANC - Mucosa0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Infection with unknown ANC - Sinus0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Infection with unknown ANC - Small bowel NOS1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Infection-Other (Specify)1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Left ventricular diastolic dysfunction0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pulmonary hypertension0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Leukocytes (total WBC)11 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Lipase0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Lymphopenia5 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Magnesium, serum-high (hypermagnesemia)1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Mental status0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Mucositis/stomatitis (clinical exam) - Oral cavity0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Mucositis/stomatitis (clinical exam) - Pharynx0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Mucositis/stomatitis (functional/symp) - Oral cav0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Musculoskeletal/Soft Tissue-Other (Specify)1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Nausea1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Necrosis, GI - Small bowel NOS1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Neutrophils/granulocytes (ANC/AGC)15 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Obstruction, GI - Small bowel NOS1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Ocular/Visual-Other (Specify)0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Opportunistic inf associated w/gt=Gr 2 lymphopenia0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pain - Abdomen NOS3 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pain - Esophagus0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pain - Extremity-limb0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pain - Oral cavity0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pain - Peritoneum1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Phosphate, serum-low (hypophosphatemia)4 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Platelets16 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pleural effusion (non-malignant)1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Potassium, serum-high (hyperkalemia)2 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Potassium, serum-low (hypokalemia)3 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pulmonary/Upper Respiratory-Other (Specify)1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Rash/desquamation0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Renal failure0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Renal/Genitourinary-Other (Specify)1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0SVT and nodal arrhythmia - Atrial fibrillation1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0SVT and nodal arrhythmia - Atrial flutter0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Sodium, serum-high (hypernatremia)0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Sodium, serum-low (hyponatremia)0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Syncope (fainting)0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Typhlitis (cecal inflammation)0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Ulcer, GI - Duodenum1 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Ulceration0 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Vomiting2 Participants
Poor-risk Cohort: MDS Transformed to AMLFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Weight loss0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hemorrhage, GU - Vagina0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Acidosis (metabolic or respiratory)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Musculoskeletal/Soft Tissue-Other (Specify)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hemorrhage, GI - Duodenum0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Renal/Genitourinary-Other (Specify)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Nausea3 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hemoglobin21 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Blood/Bone Marrow-Other (Specify)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Necrosis, GI - Small bowel NOS0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Glucose, serum-high (hyperglycemia)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Vomiting0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Neutrophils/granulocytes (ANC/AGC)16 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Febrile neutropenia32 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0SVT and nodal arrhythmia - Atrial fibrillation0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Obstruction, GI - Small bowel NOS0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Fatigue (asthenia, lethargy, malaise)2 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Bilirubin (hyperbilirubinemia)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Ocular/Visual-Other (Specify)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Esophagitis0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Ulcer, GI - Duodenum0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Opportunistic inf associated w/gt=Gr 2 lymphopenia2 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Edema: limb0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0SVT and nodal arrhythmia - Atrial flutter0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pain - Abdomen NOS0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Dyspnea (shortness of breath)2 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pain - Bone1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Dry mouth/salivary gland (xerostomia)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Anorexia0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pain - Esophagus1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Distention/bloating, abdominal0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0ALT, SGPT (serum glutamic pyruvic transaminase)2 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pain - Extremity-limb1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Diarrhea8 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Sodium, serum-high (hypernatremia)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pain - Oral cavity3 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Creatinine2 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Alkalosis (metabolic or respiratory)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pain - Peritoneum0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Constitutional Symptoms-Other (Specify)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Ulceration1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Phosphate, serum-low (hypophosphatemia)2 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Confusion0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Sodium, serum-low (hyponatremia)1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Platelets19 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Conduction abnormality - Asystole0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Alkaline phosphatase1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pleural effusion (non-malignant)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Colitis, infectious (e.g., Clostridium difficile)1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0AST, SGOT1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Infection with unknown ANC - Blood4 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Stomach1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Potassium, serum-high (hyperkalemia)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Infection with unknown ANC - Lung (pneumonia)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Small bowel0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Carbon monoxide diffusion capacity (DL(co))1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Infection with unknown ANC - Mucosa1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Skin0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Sinus0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Syncope (fainting)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Infection with unknown ANC - Sinus0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Meninges1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Potassium, serum-low (hypokalemia)3 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Infection with unknown ANC - Small bowel NOS0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Lung6 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pulmonary hypertension0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Infection-Other (Specify)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Kidney1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Cardiac General-Other (Specify)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Left ventricular diastolic dysfunction0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Albumin, serum-low (hypoalbuminemia)6 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Pulmonary/Upper Respiratory-Other (Specify)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Leukocytes (total WBC)17 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Inf (clin/microbio) w/Gr 3-4 neuts - Blood7 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Cardiac-ischemia/infarction0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Lipase0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Ileus, GI (functional obstruction of bowel)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Weight loss2 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Lymphopenia9 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hypoxia3 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Rash/desquamation1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Magnesium, serum-high (hypermagnesemia)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hypotension1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Calcium, serum-low (hypocalcemia)3 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Mental status0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hypertension0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Typhlitis (cecal inflammation)1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Mucositis/stomatitis (clinical exam) - Oral cavity1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hemorrhage/Bleeding-Other (Specify)0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Renal failure2 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hemorrhage, pulmonary/upper respiratory - Nose1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Mucositis/stomatitis (clinical exam) - Pharynx1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS1 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Bone marrow cellularity0 Participants
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0Mucositis/stomatitis (functional/symp) - Oral cav1 Participants
Other Pre-specified

Correlation Between Pre-study Cytogenetic Features and Response

Time frame: 5 years

Other Pre-specified

Overall Survival (OS)

OS is calculated for all participants from the date of initial registration on study until death from any cause. Observations for participants last known to be alive were censored.

Time frame: OS assessed for up to 5 years, median OS reported

Population: Eligible participants who started treatment

ArmMeasureValue (MEDIAN)
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthOverall Survival (OS)10 months
Poor-risk Cohort: MDS Transformed to AMLOverall Survival (OS)10 months
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionOverall Survival (OS)4 months
Other Pre-specified

Relapse-free Survival (RFS)

RFS is calculated for participants who have achieved a complete response (CR) or CR with incomplete blood count recovery (CRi). RFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse. Per the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, morphologic complete remission requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL.

Time frame: RFS assessed for up to 5 years, median RFS reported

Population: Eligible participants who started treatment

ArmMeasureValue (MEDIAN)
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthRelapse-free Survival (RFS)9 months
Poor-risk Cohort: MDS Transformed to AMLRelapse-free Survival (RFS)19.4 months
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionRelapse-free Survival (RFS)2.7 months

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026