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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NCT00943553 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-04-13

No results posted yet for this study

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.

Conditions

  • Acute Myelogenous Leukemia (AML)

Interventions

DRUG

decitabine Induction Chemotherapy

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)

DRUG

Induction Chemotherapy

Arm B - 7 days (7 days of induction chemotherapy with IV daunorubicin 45 mg/m\^2 and cytarabine 100 mg/m\^2/day only)

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Peter Tarassoff, MD · Eisai Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-08-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00943553 on ClinicalTrials.gov