The purpose of this study is to evaluate the efficacy and safety of decitabine when used before chemotherapy to treat leukemia in pediatric patients. The study will also evaluate the ways decitabine is affected or changed when used in the human body.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Arm A - 12 days (5 days of intravenous (IV) decitabine 20 mg/m\^2 followed by 7 days of induction chemotherapy with IV daunorubicin 45 mg/m\^2 and cytarabine 100 mg/m\^2/day)
Arm B - 7 days (7 days of induction chemotherapy with IV daunorubicin 45 mg/m\^2 and cytarabine 100 mg/m\^2/day only)
Unnamed facility
New Delhi, New Delhi, India
Primary Endpoint (Core Component): Complete Remission (CR) Rate as defined by International Working Group - 2003 criteria
Time frame: ~ 2 years
Secondary Endpoint (Core Component): Methylation of DNA following decitabine therapy.
Time frame: Until Week 3 after chemotherapy
Secondary Endpoint (Core Component): Time to platelet recovery (≥ 100,000/mm3) and time to neutrophil recovery (absolute neutrophil count [ANC] ≥ 1000/mm3) following induction chemotherapy
Time frame: Until ~ 4 weeks after last dose of induction chemotherapy
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