Status:
TERMINATED
A Study of Decitabine (DACOGEN) in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
1-18 years
Phase:
PHASE1
PHASE2
Brief 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).
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 admin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 22 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2017
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01853228
Start Date
October 22 2013
End Date
August 28 2017
Last Update
June 17 2019
Active Locations (17)
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1
Ghent, Belgium
2
Copenhagen Ø, Denmark
3
Paris, France
4
Toulouse, France