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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00943553
Recruitment Status : Withdrawn (Terminated by Sponsor)
First Posted : July 22, 2009
Last Update Posted : April 13, 2015
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Tracking Information
First Submitted Date  ICMJE July 21, 2009
First Posted Date  ICMJE July 22, 2009
Last Update Posted Date April 13, 2015
Study Start Date  ICMJE June 2010
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2010)
Primary Endpoint (Core Component): Complete Remission (CR) Rate as defined by International Working Group - 2003 criteria [ Time Frame: ~ 2 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2009)
Primary Endpoint (Core Component): Complete Remission (CR) Rate as defined by International Working Group - 2003 criteria (Cheson et al, 2003) [ Time Frame: ~ 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2009)
  • Secondary Endpoint (Core Component): Methylation of DNA following decitabine therapy. [ Time Frame: Until Week 3 after chemotherapy ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myelogenous Leukemia (AML)
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: decitabine Induction Chemotherapy
  • Experimental: 2
    Intervention: Drug: Induction Chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 10, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2009)
40
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00943553
Other Study ID Numbers  ICMJE E7373-G000-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Inc.
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Peter Tarassoff, MD Eisai Inc.
PRS Account Eisai Inc.
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP