Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects
NCT ID: NCT01177540
Last Updated: 2022-06-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
25 participants
INTERVENTIONAL
2011-03-03
2013-07-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Decitabine
5 day priming with decitabine followed by Induction Chemotherapy of ADE (daunorubicin, cytarabine, etoposide).
Arm B
Decitabine
Induction Chemotherapy of ADE (daunorubicin, cytarabine, etoposide) only
Interventions
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Decitabine
5 day priming with decitabine followed by Induction Chemotherapy of ADE (daunorubicin, cytarabine, etoposide).
Decitabine
Induction Chemotherapy of ADE (daunorubicin, cytarabine, etoposide) only
Eligibility Criteria
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Inclusion Criteria
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
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.
1 Year
16 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eisai Medical Services
Role: STUDY_DIRECTOR
Eisai Inc.
Locations
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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
New York, New York, United States
Charlotte, North Carolina, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
New Lambton Heights, New South Wales, Australia
Westmead, New South Wales, Australia
Parkville, Victoria, Australia
Subiaco, Western Australia, Australia
Calgary, Alberta, Canada
Countries
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References
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Gore L, Triche TJ Jr, Farrar JE, Wai D, Legendre C, Gooden GC, Liang WS, Carpten J, Lee D, Alvaro F, Macy ME, Arndt C, Barnette P, Cooper T, Martin L, Narendran A, Pollard J, Meshinchi S, Boklan J, Arceci RJ, Salhia B. A multicenter, randomized study of decitabine as epigenetic priming with induction chemotherapy in children with AML. Clin Epigenetics. 2017 Oct 5;9:108. doi: 10.1186/s13148-017-0411-x. eCollection 2017.
Other Identifiers
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E7373-G000-202
Identifier Type: -
Identifier Source: org_study_id
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