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


Phase 1/Phase 2
1 Month
18 Years
Not Enrolling
Both
Acute Myeloid Leukemia

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Trial Information

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


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 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase 1 maximum tolerable dose of cytarabine

Outcome Time Frame:

Cycle 1 Day 28

Safety Issue:

No

Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC

Authority:

United States: Food and Drug Administration

Study ID:

CR102071

NCT ID:

NCT01853228

Start Date:

August 2013

Completion Date:

March 2018

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute myeloid leukemia
  • Relapsed or refractory acute myeloid leukemia
  • Children
  • Decitabine
  • DACOGEN
  • Cytarabine
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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