Clinical trial · Interventional
A Study of Decitabine (DACOGEN) in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia
Phase 1-2 Safety and Efficacy Study of DACOGEN in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia
NCT01853228CI-TRIAL-00039091terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): EMA/PDCO acknowledged that available results from this study do not support further clinical studies in relapsed/refractory AML paediatric patients.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phase1 and Phase 2: decitabine | Drug | — | UNRESOLVED |
| Phase 1: cytarabine | Drug | — | UNRESOLVED |
| Phase 2: cytarabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Decitabine and cytarabine
- interventionNames
- Drug: Phase1 and Phase 2: decitabine
- Drug: Phase 1: cytarabine
- Drug: Phase 2: cytarabine
Primary outcomes (6)
- measure
- Phase 1: Maximum Tolerated Dose (MTD) of Cytarabine
- timeFrame
- Cycle 1 (42 days)
- description
- The maximum tolerated dose (MTD) for cytarabine was based on the number of participants experiencing a dose-limiting toxicity (DLT) by the end of Cycle 1. A non-hematological DLT was defined as: any Grade \>=3 toxicity that persists for greater than (\>) 5 days or any Grade 2 toxicity that persists for \>7 days and that is intolerable to the participant. A hematological DLT was defined as Grade 4 neutropenia or thrombocytopenia due to a hypoplastic bone marrow at Day 42, in the absence of malignant infiltration. The nominal duration of each cycle was 28 days. However, participants who had not experienced bone marrow recovery at Day 28 were followed up to Day 42. Failure of marrow recovery (improvement to Grade 3) by Day 42 was considered a DLT. The maximum duration of Cycle 1 was therefore 42 days.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of acute myeloid leukemia (AML) according to the World Health Organization (WHO) classification * Diagnosis of AML which has relapsed or is refractory to standard of care and no curative therapy exists * Karnofsky or Lansky score of at least 50 * Must be recovered from acute toxicity of any prior treatment * Must have adequate organ function according to protocol-defined criteria * Agrees to protocol-defined use of effective contraception * Female participants of childbearing potential must have a negative serum or urine pregnancy test at Day 1 of Cycle 1 Exclusion Criteria: * Prior treatment with decitabine or azacitidine * Acute promyelocytic leukemia (M3 subtype in the French-American-British \[FAB\] classification system) * CNS3 disease * acute myeloid leukemia (AML) associated with congenital syndromes such as Down syndrome, Fanconi anemia, Bloom syndrome, Kostmann syndrome or Diamond-Blackfan anemia, or bone marrow failure associated with inherited syndromes * White blood cell count greater than 40x10\^9 cells/liter(L) * Known allergies, hypersensitivity, or intolerance to decitabine or cytarabine or their excipients * Contraindications to the use of cytarabine per local prescribing information or prior adverse reactions to cytarabine which would prevent further use * Currently enrolled in the treatment phase of an interventional investigational study * Female who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study drug (however, the period after which it becomes safe to become pregnant after the last dose of treatment is not known) * Male who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug * Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments * Any social or medical condition that in the investigator's opinion renders the participant unfit for study participation * History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease * History of human immunodeficiency virus (HIV) antibody positive
References
Publications (0)
Data not yet available
No reference posted for this study.