A Study of Decitabine (DACOGEN) in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia
Acute Myeloid Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
Acute myeloid leukemia, Relapsed or refractory acute myeloid leukemia, Children, Decitabine, DACOGEN, Cytarabine
Study Type
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Phase1 and Phase 2: decitabine Type: Drug
Name: Phase 1: cytarabine Type: Drug
Name: Phase 2: cytarabine Type: Drug
Overall Status
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).
Detailed Description
This is an open-label (identity of assigned study drug will be known) study to evaluate safety, efficacy, and pharmacokinetics (study of what the body does to a drug) of decitabine in sequential administration with cytarabine in children with relapsed or refractory AML. The study will determine the maximum tolerated dose of cytarabine that can be given following decitabine (Phase 1) and the response rate to this combination (Phase 2). Participants may enter a continuation phase of single agent-decitabine infusions for as long as such treatment would be considered beneficial. Serial pharmacokinetic samples will be collected and safety and efficacy will be monitored throughout the study.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 18 Years
Minimum Age: 1 Month
Gender: Both
Criteria: 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 40,000 cells/mL

- 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
Gent, Belgium
Status: Recruiting
Copenhagen Ø, Denmark
Status: Recruiting
Paris, France
Status: Recruiting
Toulouse Cedex 9, France
Status: Recruiting
Vandoeuvre-Lès-Nancy, France
Status: Recruiting
Essen, Germany
Status: Recruiting
Hamburg, Germany
Status: Recruiting
Hannover, Germany
Status: Recruiting
Stuttgart, Germany
Status: Recruiting
Rotterdam, Netherlands
Status: Recruiting
Barcelona, Spain
Status: Recruiting
Madrid, Spain
Status: Recruiting
Valencia, Spain
Status: Recruiting
Birmingham, United Kingdom
Status: Recruiting
Bristol, United Kingdom
Status: Withdrawn
Cambridge, United Kingdom
Status: Recruiting
Glasgow, United Kingdom
Status: Recruiting
Sutton, United Kingdom
Status: Recruiting
Start Date
October 2013
Completion Date
August 2019
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page