Phase 1-2 Safety and Efficacy Study of DACOGEN in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia.

Janssen-Cilag International NV0 sites33 target enrollmentFebruary 21, 2014

Overview

No summary available.

Registry

who.int

Start Date

February 21, 2014

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 33
•F.1\.2 Adults (18\-64 years) no

•\- Prior treatment with decitabine or azacitidine
•\- Acute promyelocytic leukemia (M3 subtype in the French\-American\-British \[FAB] classification system)
•\- CNS3 disease
•\- 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