drugset / Trial / NCT00943553

A Randomized Study of Epigenetic Priming Using Decitabine With Front Line Induction Chemotherapy Compared With Immediate Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects

NCT00943553

Phase 2 Withdrawn Eisai Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2010-06
Primary completion
2011-08
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 20 mg/m2 Intravenous
Background Cytarabine Small molecule 100 mg/m2 Intravenous
Background Daunorubicin Small molecule 45 mg/m2 Intravenous