Conditions: Pediatric Acute Myelogenous Leukemia (AML)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 25
Healthy volunteers: no

Brief summary:
The purpose of this study is to provide data on the activity of a standard daunorubicin, cytarabine, and etoposide (ADE) induction plus epigenetic priming with decitabine as assessed by standard measures of complete remission (CR), leukemia free survival (LFS) and overall survival (OS), as well as, on minimal residual disease (MRD). It will also provide necessary data on the safety and Pharmacokinetics (PK) of decitabine in pediatric patients that is currently unavailable.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Decitabine intervention 2: Decitabine
Intervention descriptions: intervention 1: 5 day priming with decitabine followed by Induction Chemotherapy of ADE (daunorubicin, cytarabine, etoposide). intervention 2: Induction Chemotherapy of ADE (daunorubicin, cytarabine, etoposide) only

Protocol document: