A Randomized Study of Epigenetic Priming Using Decitabine With Front Line Induction Chemotherapy Compared With Immediate Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects

This study has been terminated.
(Terminated by Sponsor)
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00943553
First received: July 21, 2009
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to evaluate the efficacy and safety of decitabine when used before chemotherapy to treat leukemia in pediatric patients. The study will also evaluate the ways decitabine is affected or changed when used in the human body.


Condition Intervention Phase
Acute Myelogenous Leukemia (AML)
Drug: decitabine Induction Chemotherapy
Drug: Induction Chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study of Epigenetic Priming Using Decitabine With Front Line Induction Chemotherapy Compared With Immediate Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects.

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Primary Endpoint (Core Component): Complete Remission (CR) Rate as defined by International Working Group - 2003 criteria [ Time Frame: ~ 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary Endpoint (Core Component): Methylation of DNA following decitabine therapy. [ Time Frame: Until Week 3 after chemotherapy ] [ Designated as safety issue: No ]
  • Secondary Endpoint (Core Component): Time to platelet recovery (≥ 100,000/mm3) and time to neutrophil recovery (absolute neutrophil count [ANC] ≥ 1000/mm3) following induction chemotherapy [ Time Frame: Until ~ 4 weeks after last dose of induction chemotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2010
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: decitabine Induction Chemotherapy
Arm A - 12 days (5 days of intravenous (IV) decitabine 20 mg/m^2 followed by 7 days of induction chemotherapy with IV daunorubicin 45 mg/m^2 and cytarabine 100 mg/m^2/day)
Other Name: E7373
Experimental: 2 Drug: Induction Chemotherapy
Arm B - 7 days (7 days of induction chemotherapy with IV daunorubicin 45 mg/m^2 and cytarabine 100 mg/m^2/day only)
Other Name: E7373

  Eligibility

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females, age 1 to16 years, inclusive
  2. Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) at Visit 1 (Screening) and a negative urine pregnancy test prior to starting study drugs (Visit 2). Female subjects of childbearing potential must agree to be abstinent or to use a highly effective method of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intrauterine devise (IUD), or have a vasectomised partner) for at least one menstrual cycle prior to starting study drug(s) and throughout the longer of either Core Study period or 30 days after the last dose of study drug. Those females using hormonal contraceptives must also be using an additional approved method of contraception (as described previously).
  3. Sexually mature male patients who are not abstinent or have not undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use a highly effective method of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously).
  4. Diagnosis of acute myelogenous leukemia (AML)(bone marrow or peripheral blood blasts ≥ 20%)
  5. Adequate cardiac function as defined by an echocardiogram or multiple gated acquisition (MUGA) scan demonstrating an ejection fraction within normal limits
  6. Are willing and able to comply with all aspects of the protocol
  7. Provide written informed consent from subject's guardian or legally authorized representative and child assent (if applicable)

Exclusion Criteria:

  1. Females who are pregnant (positive β-hCG test) or lactating
  2. History of chronic myelogenous leukemia (CML) [t(9;22)]
  3. Acute promyelocytic leukemia (M3 subtype in French-American-British [FAB] classification).
  4. Known central nervous system (CNS) leukemia
  5. AML associated with congenital syndromes such as Down syndrome, Fanconi anemia, Bloom syndrome, Kostmann syndrome, or Diamond Blackfan anemia
  6. White blood cell (WBC) count > 40,000/mm3
  7. Serum creatinine > 2.5 mg/dL
  8. Alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN) and/or total bilirubin > 3 x ULN
  9. Prior chemotherapy (other than hydroxyurea) or radiation therapy for AML
  10. Known to be human immunodeficiency virus (HIV) positive
  11. Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject's ability to safely complete the study
  12. The Investigator believes the subject to be medically unfit to receive the study drug or unsuitable for any other reason.
  13. Subject with hypersensitivity to decitabine, daunorubicin, or cytarabine
  14. Has participated in a drug trial in the last 4 weeks
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943553

Locations
India
New Delhi, India, 110085
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Peter Tarassoff, MD Eisai Inc.
  More Information

No publications provided

Responsible Party: Peter Tarassoff, MD / Executive Director, Oncology, Eisai Medical Research
ClinicalTrials.gov Identifier: NCT00943553     History of Changes
Other Study ID Numbers: E7373-G000-201
Study First Received: July 21, 2009
Last Updated: March 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014