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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.


Phase 2
1 Year
16 Years
Not Enrolling
Both
Acute Myelogenous Leukemia (AML)

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

~ 2 years

Safety Issue:

No

Principal Investigator

Peter Tarassoff, MD

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

E7373-G000-201

NCT ID:

NCT00943553

Start Date:

June 2010

Completion Date:

Related Keywords:

  • Acute Myelogenous Leukemia (AML)
  • AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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