Trials / Withdrawn
WithdrawnNCT00943553
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
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.
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 1 Year – 16 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2011-08-01
- First posted
- 2009-07-22
- Last updated
- 2015-04-13
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT00943553. Inclusion in this directory is not an endorsement.