Trial Outcomes & Findings for Clofarabine Plus Low-Dose Cytarabine Induction and Decitabine Consolidation in Frontline Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS) (NCT NCT00778375)

Last Updated: 2016-07-14

Results Overview

Disease (DFS) or Relapse-free survival (RFS): Time from date of treatment start until the date of first objective documentation of disease-relapse; Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy and then every 2 weeks (+/- 7 days) as required by leukemia evolution until remission or non-response. Among participants who achieved CR or CRp, RFS was defined as the time interval between the date of response (ie CR or CRp) and the date of relapse or date of death, whichever occurs first. CR or CRp participants who were alive and relapse-free were censored at the off-study date. Full range reflects time to disease progression only, therefore does not reflect a lesser survival time due to other reasons than disease progression/relapse.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

122 participants

Primary outcome timeframe

Evaluated from treatment date until date of disease progression/relapse, followed for 5 years/60 months.

Results posted on

2016-07-14

Participant Flow

Recruitment Period: October 20, 2008 through October 24, 2011. All recruitment done at The University of Texas MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Clofarabine + Cytarabine + Decitabine Clofarabine 20 mg/m\^2 by vein (IV) as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m\^2 as 1-2 hour infusion daily for 5 days.
Overall Study STARTED	122
Overall Study COMPLETED	119
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Clofarabine + Cytarabine + Decitabine Clofarabine 20 mg/m\^2 by vein (IV) as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m\^2 as 1-2 hour infusion daily for 5 days.
Overall Study Ineligible	3

Baseline Characteristics

Clofarabine Plus Low-Dose Cytarabine Induction and Decitabine Consolidation in Frontline Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clofarabine + Cytarabine + Decitabine n=122 Participants Clofarabine 20 mg/m\^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m\^2 as 1-2 hour infusion daily for 5 days.
Age, Continuous	68 years n=99 Participants
Sex: Female, Male Female	44 Participants n=99 Participants
Sex: Female, Male Male	78 Participants n=99 Participants
Region of Enrollment United States	122 participants n=99 Participants

PRIMARY outcome

Timeframe: Evaluated from treatment date until date of disease progression/relapse, followed for 5 years/60 months.

Population: One participant of 119 treated was not evaluable for outcome.

Outcome measures

Outcome measures
Measure	Clofarabine + Cytarabine + Decitabine n=118 Participants Clofarabine 20 mg/m\^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m\^2 as 1-2 hour infusion daily for 5 days.	Re-Induction Clofarabine 20 mg/m\^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m\^2 as 1-2 hour infusion daily for 5 days.
Disease-free (DFS) or Relapse-free Survival (RFS) Time	15.9 Months Interval 0.3 to 48.3	—

PRIMARY outcome

Timeframe: Evaluation following two 10 day cycles on day 21 of therapy, continuing up to 210 days

Population: The outcome population consisted of first sixty participants enrolled between October 2008 and January 2010, of whom 59 were evaluable for response.

All responses were defined as per IWG criteria (2003) where CR Rate defined as number of participants with CR out of total treated participants. Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 times 10\^9/L and platelet count \> 100 times 10\^9/L, and normal bone marrow differential (\< 5% blasts). Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy.

Outcome measures

Outcome measures
Measure	Clofarabine + Cytarabine + Decitabine n=59 Participants Clofarabine 20 mg/m\^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m\^2 as 1-2 hour infusion daily for 5 days.	Re-Induction Clofarabine 20 mg/m\^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m\^2 as 1-2 hour infusion daily for 5 days.
Complete Remission (CR) Rate for First 60 Participants	58 Percentage of Participants	—

PRIMARY outcome

Timeframe: Evaluated from treatment date until date of death, followed for 5 years/60 months.

Population: One participant of 119 treated was not evaluable for outcome.

Overall survival (OS): Time from date of treatment start until date of death due to any cause.

Outcome measures

Outcome measures
Measure	Clofarabine + Cytarabine + Decitabine n=118 Participants Clofarabine 20 mg/m\^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m\^2 as 1-2 hour infusion daily for 5 days.	Re-Induction Clofarabine 20 mg/m\^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m\^2 as 1-2 hour infusion daily for 5 days.
Median Overall Survival (OS) Overall Survival	11.1 Months Interval 0.2 to 53.9	—
Median Overall Survival (OS) Overall Survival among Responders ((n=86)	21.1 Months Interval 1.3 to 53.9	—

PRIMARY outcome

Timeframe: Beginning assessment following two 10-day induction cycles through an additional re-induction cycle, up to 40 days

Population: One participant of 119 treated was not evaluable for response. Twenty-two participants required re-induction.

All responses were defined as per IWG criteria (2003) where CR Rate defined as number of participants with CR out of total treated participants. Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 times 10\^9/L and platelet count \> 100 times 10\^9/L, and normal bone marrow differential (\< 5% blasts). Complete response with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts. Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy.

Outcome measures

Outcome measures
Measure	Clofarabine + Cytarabine + Decitabine n=118 Participants Clofarabine 20 mg/m\^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m\^2 as 1-2 hour infusion daily for 5 days.	Re-Induction n=22 Participants Clofarabine 20 mg/m\^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m\^2 as 1-2 hour infusion daily for 5 days.
Number of Participants With Complete Remission [Complete Response (CR), Complete Response With Platelet Recover (CRp) or Complete Response With Incomplete Marrow Recovery (CRi)] CR	60 Participants	12 Participants
Number of Participants With Complete Remission [Complete Response (CR), Complete Response With Platelet Recover (CRp) or Complete Response With Incomplete Marrow Recovery (CRi)] CRp/CRi	9 Participants	4 Participants

SECONDARY outcome

Timeframe: Follow up up to 5 years/60 months.

Population: Of 119 enrolled, one participant was not evaluable for response.

EFS is defined as length of time after primary treatment for a cancer ends that the participant remains free of certain complications or events that the treatment was intended to prevent or delay, for example but not exclusive of hematologic and non-hematologic toxicities, cumulative toxicities with consolidation courses, or emergence of resistance to the chemotherapy component of treatment.

Outcome measures

Outcome measures
Measure	Clofarabine + Cytarabine + Decitabine n=118 Participants Clofarabine 20 mg/m\^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m\^2 as 1-2 hour infusion daily for 5 days.	Re-Induction Clofarabine 20 mg/m\^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m\^2 as 1-2 hour infusion daily for 5 days.
Event Free Survival (EFS)	7.7 Months Interval 0.2 to 49.5	—

SECONDARY outcome

Timeframe: Beginning assessment following two 10-day induction cycles through an additional re-induction cycle, up to 40 days

Population: Of 119 enrolled, one participant was not evaluable for response.

IWG Response criteria (2003): Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 times 10\^9/L and platelet count \> 100 times 10\^9/L, and normal bone marrow differential (\< 5% blasts). Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of \< 100 x 10\^9/L or Complete remission with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts; Partial Remission (PR): Blood count recovery as for CR, but with both a decrease in marrow blasts of at least 50% and not more than 6 to 25% abnormal cells in the marrow. Participants not achieving a complete remission following first induction course, can receive a second induction course at least 28 days following first to optimize response if possible.

Outcome measures

Outcome measures
Measure	Clofarabine + Cytarabine + Decitabine n=118 Participants Clofarabine 20 mg/m\^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m\^2 as 1-2 hour infusion daily for 5 days.	Re-Induction Clofarabine 20 mg/m\^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m\^2 as 1-2 hour infusion daily for 5 days.
Overall Response Rate (CR, CRp/CRi and PR)	73 Percentage of Participants	—

Adverse Events

Clofarabine + Cytarabine + Decitabine

Serious events: 12 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Clofarabine + Cytarabine + Decitabine n=119 participants at risk Clofarabine 20 mg/m\^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m\^2 as 1-2 hour infusion daily for 5 days.
General disorders Sudden death	1.7% 2/119 • Number of events 2 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
General disorders Death	1.7% 2/119 • Number of events 2 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Infections and infestations Infection	4.2% 5/119 • Number of events 5 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease Progression	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Blood and lymphatic system disorders Hemorrhage/Bleeding	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Infections and infestations Pneumonia	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Blood and lymphatic system disorders Bone marrow hypocellular	5.9% 7/119 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).

Other adverse events

Other adverse events
Measure	Clofarabine + Cytarabine + Decitabine n=119 participants at risk Clofarabine 20 mg/m\^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m\^2 as 1-2 hour infusion daily for 5 days.
Gastrointestinal disorders Abdominal infection	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Gastrointestinal disorders Abdominal pain	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Investigations Alanine aminotransferase increased	2.5% 3/119 • Number of events 3 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Immune system disorders Allergic rhinitis	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Psychiatric disorders Anxiety	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Investigations Aspartate aminotransferase increased	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Cardiac disorders Atrial fibrillation	1.7% 2/119 • Number of events 2 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Investigations Bilirubin increased	3.4% 4/119 • Number of events 4 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Blood and lymphatic system disorders Blood/Bone Marrow (Other)	1.7% 2/119 • Number of events 2 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Cardiac disorders Cardiac arrhythmia (Other)	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Gastrointestinal disorders Colitis, infectious (e.g., Clostridium difficile)	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Psychiatric disorders Confusion	1.7% 2/119 • Number of events 2 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Psychiatric disorders Constipation	1.7% 2/119 • Number of events 2 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Investigations Creatinine increased	1.7% 2/119 • Number of events 2 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Metabolism and nutrition disorders Dehydration	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Blood and lymphatic system disorders Febrile neutropenia	26.1% 31/119 • Number of events 43 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
General disorders Fever	5.9% 7/119 • Number of events 7 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Nervous system disorders Headache	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Vascular disorders Hematoma	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Renal and urinary disorders Hemorrhage urinary tract	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Blood and lymphatic system disorders Hemorrhage/Bleeding (Other)	2.5% 3/119 • Number of events 3 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Nervous system disorders Hypersensitivity	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Vascular disorders Hypertension	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Vascular disorders Hypotension	1.7% 2/119 • Number of events 2 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Infections and infestations Infection	21.8% 26/119 • Number of events 40 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Infections and infestations Infection - Neck	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Infections and infestations Infection (Other) - 10021789 / CTCAE3.M10	1.7% 2/119 • Number of events 2 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Nervous system disorders Intracranial hemorrhage	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Nervous system disorders Ischemia cerebrovascular	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Nervous system disorders Neurology (Other)	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
General disorders Pain (Other)	2.5% 3/119 • Number of events 3 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Respiratory, thoracic and mediastinal disorders Pneumonia	3.4% 4/119 • Number of events 4 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Respiratory, thoracic and mediastinal disorders Pulmonary (Other)	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Skin and subcutaneous tissue disorders Rash desquamating	2.5% 3/119 • Number of events 3 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Renal and urinary disorders Renal failure	5.0% 6/119 • Number of events 6 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Nervous system disorders Seizure	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Metabolism and nutrition disorders Serum sodium decreased	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Infections and infestations Sinusitis	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Nervous system disorders Syncope	2.5% 3/119 • Number of events 3 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Metabolism and nutrition disorders Tumor lysis syndrome	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Renal and urinary disorders Urinary retention	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).
Renal and urinary disorders Urinary tract infection	0.84% 1/119 • Number of events 1 • Adverse events captured from the time of the first treatment, until 30 days after the last dose of drug. Treatment could last up to nineteen 10-day cycles (approximately 200 days).

Additional Information

Farhad Ravandi-Kashani, Professor, Leukemia Department

University of Texas (UT) MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place