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

Eisai

Status and phase

Terminated

Phase 2

Conditions

Pediatric Acute Myelogenous Leukemia (AML)

Treatments

Drug: Decitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01177540

E7373-G000-202

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

1 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Males and females, age 1 to 16 years, inclusive
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)
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)
Diagnosis of acute myelogenous leukemia ( AML) (bone marrow or peripheral blood blasts greater than or equal to 20%)
Adequate cardiac function as defined by an echocardiogram or multiple gated acquisition (MUGA) scan demonstrating an ejection fraction greater than 50%
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).

Exclusion Criteria

Females who are pregnant (positive B-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 greater than 100,000/mm3
Serum creatinine greater than 2.5 mg/dL
Alanine aminotransferase (ALT) greater than 5 x upper limit of normal (ULN) and/or total bilirubin greater than 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, cytarabine, or etoposide
Has participated in a drug trial in the last 4 weeks.