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

NCT00943553 | Withdrawn Phase 2

• 1 other identifier: E7373-G000-201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myelogenous Leukemia (AML)

Keywords

AML

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint (Core Component): Complete Remission (CR) Rate as defined by International Working Group - 2003 criteria

  ~ 2 years

Secondary Outcomes (2)

• Secondary Endpoint (Core Component): Methylation of DNA following decitabine therapy.

  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

  Until ~ 4 weeks after last dose of induction chemotherapy

Study Arms (2)

1

EXPERIMENTAL

Drug: decitabine Induction Chemotherapy

2

EXPERIMENTAL

Drug: Induction Chemotherapy

Interventions

decitabine Induction Chemotherapy DRUG

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)

Also known as: E7373

1

Induction Chemotherapy DRUG

Arm B - 7 days (7 days of induction chemotherapy with IV daunorubicin 45 mg/m\^2 and cytarabine 100 mg/m\^2/day only)

Also known as: E7373

2

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males and females, age 1 to16 years, inclusive
• 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).
• 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).
• Diagnosis of acute myelogenous leukemia (AML)(bone marrow or peripheral blood blasts ≥ 20%)
• Adequate cardiac function as defined by an echocardiogram or multiple gated acquisition (MUGA) scan demonstrating an ejection fraction within normal limits
• Are willing and able to comply with all aspects of the protocol
• Provide written informed consent from subject's guardian or legally authorized representative and child assent (if applicable)

You may not qualify if:

• Females who are pregnant (positive β-hCG test) or lactating
• History of chronic myelogenous leukemia (CML) \[t(9;22)\]
• Acute promyelocytic leukemia (M3 subtype in French-American-British \[FAB\] classification).
• Known central nervous system (CNS) leukemia
• AML associated with congenital syndromes such as Down syndrome, Fanconi anemia, Bloom syndrome, Kostmann syndrome, or Diamond Blackfan anemia
• White blood cell (WBC) count \> 40,000/mm3
• Serum creatinine \> 2.5 mg/dL
• Alanine aminotransferase (ALT) \> 5 x upper limit of normal (ULN) and/or total bilirubin \> 3 x ULN
• Prior chemotherapy (other than hydroxyurea) or radiation therapy for AML
• Known to be human immunodeficiency virus (HIV) positive
• 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
• The Investigator believes the subject to be medically unfit to receive the study drug or unsuitable for any other reason.
• Subject with hypersensitivity to decitabine, daunorubicin, or cytarabine
• Has participated in a drug trial in the last 4 weeks

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Unknown Facility

New Delhi, New Delhi, 110085, India

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Induction Chemotherapy

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Remission Induction

Study Officials

• Peter Tarassoff, MD

  Eisai Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 22, 2009
• Study Start: June 1, 2010
• Primary Completion: August 1, 2011
• Last Updated: April 13, 2015

Record last verified: 2015-04

Locations

IN (1)