Trial Outcomes & Findings for Higher or Lower Dose Cladribine, Cytarabine, and Mitoxantrone in Treating Medically Less Fit Patients With Newly Diagnosed Acute Myeloid Leukemia or Myeloid Neoplasm (NCT NCT03012672)

Last Updated: 2022-03-08

Results Overview

Randomizing patients to either intensive or non-intensive induction and post remission chemotherapy will be considered feasible if the true proportion of patients willing to be randomized is 60% or higher.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

At end of enrollment

Results posted on

2022-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Higher-dose) INDUCTION: Patients receive G-CSF SC on days 0-5, higher dose cladribine IV over 2 hours on days 1-5, higher dose cytarabine IV over 2 hours on days 1-5, and higher dose mitoxantrone IV over 60 minutes on days 1-3. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi with up to 2 courses of Induction receive G-CSF, cladribine, and cytarabine as in Induction. Courses repeat every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.	Arm II (Lower-dose) INDUCTION: Patients receive G-CSF SC on days 0-5, lower dose cladribine IV over 2 hours on days 1-5, lower dose cytarabine IV over 1 hour on days 1-5, and lower dose mitoxantrone IV over 60 minutes on days 1-3. Treatment repeats every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi with up to 6 courses of Induction receive G-CSF, cladribine, and cytarabine as in Induction. Courses repeat every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	20	30
Overall Study COMPLETED	20	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Higher or Lower Dose Cladribine, Cytarabine, and Mitoxantrone in Treating Medically Less Fit Patients With Newly Diagnosed Acute Myeloid Leukemia or Myeloid Neoplasm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ARM I (HIGHER-DOSE) n=20 Participants ARM I (HIGHER-DOSE): INDUCTION: Patients receive granulocyte colony-stimulating factor (G-CSF) subcutaneously (SC) on days 0-5, higher dose cladribine intravenously (IV) over 2 hours on days 1-5, higher dose cytarabine IV over 2 hours on days 1-5, and higher dose mitoxantrone IV over 60 minutes on days 1-3. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve complete response (CR)/CR with incomplete count recovery (CRi) with up to 2 courses of Induction receive G-CSF, cladribine, and cytarabine as in Induction. Courses repeat every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.	ARM II (LOWER-DOSE) n=30 Participants ARM II (LOWER-DOSE): INDUCTION: Patients receive G-CSF SC on days 0-5, lower dose cladribine IV over 2 hours on days 1-5, lower dose cytarabine IV over 1 hour on days 1-5, and lower dose mitoxantrone IV over 60 minutes on days 1-3. Treatment repeats every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve complete response (CR)/CR with incomplete count recovery (CRi) with up to 6 courses of Induction receive G-CSF, cladribine, and cytarabine as in Induction. Courses repeat every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.	Total n=50 Participants Total of all reporting groups
Age, Continuous	71.5 years n=5 Participants	72 years n=7 Participants	72 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	21 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	25 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Secondary Disease De Novo	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Secondary Disease Secondary	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
ELN Risk Category Favorable	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
ELN Risk Category Intermediate	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
ELN Risk Category Adverse	9 Participants n=5 Participants	17 Participants n=7 Participants	26 Participants n=5 Participants
ELN Risk Category No Classifiable	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: At end of enrollment

Outcome measures

Outcome measures
Measure	All Patients Enrolled n=50 Participants Total number of patients enrolled
Feasibility Defined as Proportion of Patients Willing to be Randomized to Either Intensive or Non-intensive Induction and Post Remission Chemotherapy Patients/physician pairs agreed to be randomized	3 Participants
Feasibility Defined as Proportion of Patients Willing to be Randomized to Either Intensive or Non-intensive Induction and Post Remission Chemotherapy Patients/physician pairs not agreed to be randomized	47 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Will be determined by peripheral blood count and bone marrow evaluation and categorized according to criteria recommended by International Working Groups.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Information on medical complications (e.g. need for intensive care unit (ICU) level care, length of ICU stay, neutropenic fever, documented infections, bleeding, reasons for hospitalization) will be collected from the medical records from the University of Washington Medical Center (UWMC) and Seattle Cancer Care Alliance (SCCA).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Information on use of medical resources (e.g. platelet transfusions; days of IV antimicrobial therapy, total hospital length of stay) will be collected from the medical records from the University of Washington Medical Center (UWMC) and Seattle Cancer Care Alliance (SCCA).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Will be assessed for all patients. Will be determined by peripheral blood count and bone marrow evaluation and categorized according to criteria recommended by International Working Groups.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 12 months

Will be measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30. Exploratory, descriptive, and observational methods will be used.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Will be determined by peripheral blood count and bone marrow evaluation and categorized according to criteria recommended by International Working Groups.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

The differences in anti-leukemic efficacy between patients treated with lower-intensity chemotherapy and those treated with higher-intensity chemotherapy will be estimated. Exploratory, descriptive, and observational methods will be used.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 12 months

The ability of physicians and the prediction algorithm(s) to assess the likelihood of early death will be compared.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Will be evaluated.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

The costs associated with inpatient and outpatient management will be calculated using electronic billing information from the University of Washington Medical Center (UWMC) and Seattle Cancer Care Alliance (SCCA). Costs will be converted from charges using departmental cost-to-charge ratios. Descriptive information identifying major cost drivers and total/subset costs per phase of treatment will be reported.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 12 months

Will be determined by a patient preference survey. Exploratory, descriptive, and observational methods will be used.

Outcome measures

Outcome data not reported

Adverse Events

ARM I (HIGHER-DOSE):

Serious events: 9 serious events

Other events: 16 other events

Deaths: 16 deaths

ARM II (LOWER-DOSE):

Serious events: 14 serious events

Other events: 30 other events

Deaths: 25 deaths

Serious adverse events

Other adverse events

Additional Information

Anna Halpern, MD

University of Washington

Phone: 206-606-1978

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	ARM I (HIGHER-DOSE): n=20 participants at risk ARM I (HIGHER-DOSE): INDUCTION: Patients receive granulocyte colony-stimulating factor (G-CSF) subcutaneously (SC) on days 0-5, higher dose cladribine intravenously (IV) over 2 hours on days 1-5, higher dose cytarabine IV over 2 hours on days 1-5, and higher dose mitoxantrone IV over 60 minutes on days 1-3. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve complete response (CR)/CR with incomplete count recovery (CRi) with up to 2 courses of Induction receive G-CSF, cladribine, and cytarabine as in Induction. Courses repeat every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.	ARM II (LOWER-DOSE): n=30 participants at risk ARM II (LOWER-DOSE): INDUCTION: Patients receive G-CSF SC on days 0-5, lower dose cladribine IV over 2 hours on days 1-5, lower dose cytarabine IV over 1 hour on days 1-5, and lower dose mitoxantrone IV over 60 minutes on days 1-3. Treatment repeats every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve complete response (CR)/CR with incomplete count recovery (CRi) with up to 6 courses of Induction receive G-CSF, cladribine, and cytarabine as in Induction. Courses repeat every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	10.0% 2/20 • Number of events 2 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	13.3% 4/30 • Number of events 5 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
Blood and lymphatic system disorders Intracranial Hemorrhage	10.0% 2/20 • Number of events 2 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	3.3% 1/30 • Number of events 1 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
Cardiac disorders Atrial Fibrillation	5.0% 1/20 • Number of events 1 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	0.00% 0/30 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
Vascular disorders Hypotension	5.0% 1/20 • Number of events 1 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	0.00% 0/30 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
General disorders Multi-organ failure	5.0% 1/20 • Number of events 1 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	6.7% 2/30 • Number of events 2 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
Blood and lymphatic system disorders Febrile Neutropenia	30.0% 6/20 • Number of events 8 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	23.3% 7/30 • Number of events 13 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
Infections and infestations Lung Infection	5.0% 1/20 • Number of events 1 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	0.00% 0/30 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
Infections and infestations Sepsis	5.0% 1/20 • Number of events 1 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	6.7% 2/30 • Number of events 2 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
Cardiac disorders Right Ventricular Dysfunction	5.0% 1/20 • Number of events 1 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	0.00% 0/30 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
Psychiatric disorders Delirium	10.0% 2/20 • Number of events 2 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	0.00% 0/30 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
Vascular disorders Vascular Access Complication	5.0% 1/20 • Number of events 1 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	0.00% 0/30 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
General disorders Generalized Edema	5.0% 1/20 • Number of events 1 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	0.00% 0/30 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
Renal and urinary disorders Acute Kidney Injury	5.0% 1/20 • Number of events 1 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	0.00% 0/30 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
Gastrointestinal disorders Colonic Pseudo-Obstruction	5.0% 1/20 • Number of events 1 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	0.00% 0/30 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
Metabolism and nutrition disorders Nausea	5.0% 1/20 • Number of events 1 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	0.00% 0/30 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
Metabolism and nutrition disorders Anorexia	0.00% 0/20 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	3.3% 1/30 • Number of events 1 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/20 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	3.3% 1/30 • Number of events 1 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/20 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	3.3% 1/30 • Number of events 2 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
Nervous system disorders Encephalopathy	0.00% 0/20 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	3.3% 1/30 • Number of events 1 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.
Cardiac disorders Pericardial Effusion	0.00% 0/20 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.	3.3% 1/30 • Number of events 1 • AEs were collected for the duration that each patient remained on protocol. If a subject decided to terminate the study early AEs continued to be collected for up to 4 weeks after the treatment was given or until they started a new anti-leukemia therapy, whichever occurred first. Only grade ≥3 adverse events other than hematologic toxicities were recorded, graded, and reported as appropriate.