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

Janssen (J&J Innovative Medicine)

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Drug: Phase 2: cytarabine

Drug: Phase1 and Phase 2: decitabine

Drug: Phase 1: cytarabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01853228

2013-000390-70 (EudraCT Number)

DACOGENAML2004 (Other Identifier)

CR102071

Details and patient eligibility

About

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).

Full 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.

Enrollment

17 patients

Sex

All

Ages

1 month to 18 years old

Volunteers

No Healthy Volunteers

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