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

Inclusion Criteria

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

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, cytarabine, or etoposide

14. Has participated in a drug trial in the last 4 weeks.