Recruitment

Recruitment Status
Terminated
Estimated Enrollment
33

Inclusion Criterias

Histological diagnosis of acute myeloid leukemia (AML) according to the World Health Organization (WHO) classification
Must have adequate organ function according to protocol-defined criteria
Diagnosis of AML which has relapsed or is refractory to standard of care and no curative therapy exists
...
Histological diagnosis of acute myeloid leukemia (AML) according to the World Health Organization (WHO) classification
Must have adequate organ function according to protocol-defined criteria
Diagnosis of AML which has relapsed or is refractory to standard of care and no curative therapy exists
Must be recovered from acute toxicity of any prior treatment
Karnofsky or Lansky score of at least 50
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 Criterias

Any social or medical condition that in the investigator's opinion renders the participant unfit for study participation
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
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)
...
Any social or medical condition that in the investigator's opinion renders the participant unfit for study participation
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
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)
White blood cell count greater than 40x10^9 cells/liter(L)
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
Currently enrolled in the treatment phase of an interventional investigational study
Prior treatment with decitabine or azacitidine
Acute promyelocytic leukemia (M3 subtype in the French-American-British [FAB] classification system)
History of human immunodeficiency virus (HIV) antibody positive
Contraindications to the use of cytarabine per local prescribing information or prior adverse reactions to cytarabine which would prevent further use
CNS3 disease
History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease
Known allergies, hypersensitivity, or intolerance to decitabine or cytarabine or their excipients

Summary

Conditions
Acute Myeloid Leukemia
Type
Interventional
Phase
Phase 1 & Phase 2
Design
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Younger than 118 years
Gender
Both males and females

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 ...

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.

Inclusion Criterias

Histological diagnosis of acute myeloid leukemia (AML) according to the World Health Organization (WHO) classification
Must have adequate organ function according to protocol-defined criteria
Diagnosis of AML which has relapsed or is refractory to standard of care and no curative therapy exists
...
Histological diagnosis of acute myeloid leukemia (AML) according to the World Health Organization (WHO) classification
Must have adequate organ function according to protocol-defined criteria
Diagnosis of AML which has relapsed or is refractory to standard of care and no curative therapy exists
Must be recovered from acute toxicity of any prior treatment
Karnofsky or Lansky score of at least 50
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 Criterias

Any social or medical condition that in the investigator's opinion renders the participant unfit for study participation
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
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)
...
Any social or medical condition that in the investigator's opinion renders the participant unfit for study participation
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
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)
White blood cell count greater than 40x10^9 cells/liter(L)
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
Currently enrolled in the treatment phase of an interventional investigational study
Prior treatment with decitabine or azacitidine
Acute promyelocytic leukemia (M3 subtype in the French-American-British [FAB] classification system)
History of human immunodeficiency virus (HIV) antibody positive
Contraindications to the use of cytarabine per local prescribing information or prior adverse reactions to cytarabine which would prevent further use
CNS3 disease
History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease
Known allergies, hypersensitivity, or intolerance to decitabine or cytarabine or their excipients

Locations

Vandoeuvre-Lès-Nancy
Paris
Rotterdam
Madrid
Essen
...
Vandoeuvre-Lès-Nancy
Paris
Rotterdam
Madrid
Essen
Sutton
Glasgow
Gent
Stuttgart
Cambridge
Copenhagen Ø
Toulouse Cedex 9
Hannover
Hamburg
Valencia
Barcelona
Birmingham

Tracking Information

NCT #
NCT01853228
Collaborators
Not Provided
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC