Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Eisai Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Decitabine
  • Drug: Decitabine

Phase:

Phase 2

Eligibility


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.

Ages Eligible for Study

1 Year - 16 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting