drugset
drugset / Trial / NCT01853228

A Study of Decitabine (DACOGEN) in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia

NCT01853228 ↗

Phase 1/2 Terminated 17 enrolled Janssen Research & Development, LLC
SequentialOpen-labelTreatment

Summary

The purpose of this study is to examine the safety and efficacy of decitabine in sequential administration with cytarabine in children with relapsed or refractory acute myeloid leukemia (AML).

Timeline

Start
2013-10-22
Primary completion
2017-08-28
Completion
2017-08-28

Outcome

Outcome not reported

Stopped: “EMA/PDCO acknowledged that available results from this study do not support further clinical studies in relapsed/refractory AML paediatric patients.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 1 g/kg Intravenous
Subject Cytarabine Small molecule 1.5 g/kg Intravenous
Subject Cytarabine Small molecule 2 g/kg Intravenous
Subject Decitabine Small molecule 20 mg/m2 Intravenous

Indications

acute myeloid leukemia