EUCTR2013-000390-70-NLActive, not recruitingPhase 1
Phase 1-2 Safety and Efficacy Study of DACOGEN in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia.
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 33
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •- 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 33
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
Investigators
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