NCT01177540

Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects

A Randomized, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Acute Myelogenous Leukemia (AML)

Interventions

Type	Name	Description
DRUG	Decitabine	5 day priming with decitabine followed by Induction Chemotherapy of ADE (daunorubicin, cytarabine, etoposide).
DRUG	Decitabine	Induction Chemotherapy of ADE (daunorubicin, cytarabine, etoposide) only

Timeline

• Start date: 2011-03-03
• Primary completion: 2013-07-19
• Completion: 2013-07-19
• First posted: 2010-08-09
• Last updated: 2022-06-28
• Results posted: 2022-06-28

Locations

22 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study