Trial intelligence / Profile preview

Decitabine Priming in Pediatric AML

NCT00943553Phase 2

Key facts

Status: Withdrawn
Start: Jun 2010
Primary completion: Aug 2011
Countries: 1
Sponsor: Eisai Co., Ltd.
Modality: Small Molecules

Drugs: decitabine
Conditions: acute myeloid leukemia (AML)

Overview

Phase 2, randomised, open-label trial of decitabine in acute myeloid leukemia (AML) (2 arms), sponsored by Eisai Co., Ltd. Primary endpoint: Complete Remission Rate at 2 years. Planned start Jun 2010; status: withdrawn.

Design

2 arms

Study design: RandomizedOpen-label

Decitabine Priming
Decitabine 20 mg/m^2 IV daily for 5 days, followed by Daunorubicin + Cytarabine
Standard Induction
Daunorubicin + Cytarabine (Immediate)

Endpoints

Primary

Complete Remission Rate2 years

Secondary

Methylation of DNA3 weeks
Time to platelet recovery4 weeks
Time to neutrophil recovery4 weeks

Beyond the preview

Go deeper on NCT00943553.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT00943553.