Phase 1-2 Safety and Efficacy Study of DACOGEN in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia
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
- Female participants must agree not to donate eggs (ova, oocytes) for the purposes of
assisted reproduction
- Male participants must not donate sperm during the study and for 3 months after
receiving the last dose of study drug
Exclusion Criteria:
- Prior treatment with decitabine or azacitidine
- Acute promyelocytic leukemia (M3 subtype in the French-American-British [FAB]
classification system)
- Symptomatic central nervous system involvement of acute myeloid leukemia (AML)
- 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 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