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

> **NCT01853228** · PHASE1,PHASE2 · TERMINATED · sponsor: **Janssen Research & Development, LLC** · enrollment: 17 (actual)

## Conditions studied

- Acute Myeloid Leukemia

## Interventions

- **DRUG:** Phase1 and Phase 2: decitabine
- **DRUG:** Phase 1: cytarabine
- **DRUG:** Phase 2: cytarabine

## Key facts

- **NCT ID:** NCT01853228
- **Lead sponsor:** Janssen Research & Development, LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2013-10-22
- **Primary completion:** 2017-08-28
- **Final completion:** 2017-08-28
- **Target enrollment:** 17 (ACTUAL)
- **Why stopped:** EMA/PDCO acknowledged that available results from this study do not support further clinical studies in relapsed/refractory AML paediatric patients.
- **Last updated:** 2019-06-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01853228

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01853228, "A Study of Decitabine (DACOGEN) in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01853228. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*