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Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects | Clinical Trials | Clareo Health

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Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects

A Randomized, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects

NCT01177540•Eisai Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to provide data on the activity of a standard daunorubicin, cytarabine, and etoposide (ADE) induction plus epigenetic priming with decitabine as assessed by standard measures of complete remission (CR), leukemia free survival (LFS) and overall survival (OS), as well as, on minimal residual disease (MRD). It will also provide necessary data on the safety and Pharmacokinetics (PK) of decitabine in pediatric patients that is currently unavailable.

Eligibility

Age

1 - 16 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females, age 1 to 16 years, inclusive
•2. Females of childbearing potential must have a negative serum beta human chorionic gonadotropin ( B-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 Randomization Phase 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 Randomization Phase 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 greater than or equal to 20%)
•5. Adequate cardiac function as defined by an echocardiogram or multiple gated acquisition (MUGA) scan demonstrating an ejection fraction greater than 50%
•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 B-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 greater than 100,000/mm3
•7. Serum creatinine greater than 2.5 mg/dL
•8. Alanine aminotransferase (ALT) greater than 5 x upper limit of normal (ULN) and/or total bilirubin greater than 3 x ULN
•9. Prior chemotherapy (other than hydroxyurea) or radiation therapy for AML
•10. Known to be human immunodeficiency virus (HIV) positive
+4 more criteria

Locations (22)

Phoenix, Arizona, United States

Madera, California, United States

Aurora, Colorado, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Worcester, Massachusetts, United States

Rochester, Minnesota, United States

New Hyde Park, New York, United States

Key Dates

Start Date

March 3, 2011

Primary Completion Date

July 19, 2013

Completion Date

July 19, 2013

Last Updated

June 28, 2022

Enrollment

ACTUAL participants

Conditions

Pediatric Acute Myelogenous Leukemia (AML)

Interventions

Decitabine

DRUG

Decitabine

DRUG