Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission
Completed · Phase 3 · Has a placebo group
Conditions studied: Leukemia, Myeloid, Acute
In brief
This study enrolled 472 participants, aged 55 or older, with a diagnosis of de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML), and who have achieved first complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) following induction with or without consolidation chemotherapy. The study is amended to include an extension phase (EP). The EP allows participants who are currently receiving oral azacitidine and who are demonstrating clinical benefit as assessed by the investigator, to continue receiving oral azacitidine after unblinding by sponsor until the participant meets the criteria for study discontinuation or until oral azacitidine becomes commercially available and reimbursed. In addition, all participants in the placebo arm and participants who had been discontinued from the treatment phase (irrespective of randomization arm) and continuing in the follow-up phase will be followed for survival in the EP.
Key facts
- Study ID
- NCT01757535
- Run by
- Celgene
- People needed
- 472
- Starts
- 2013-04-24
- Expected to finish
- 2024-06-18
- Last updated by the study team
- 2025-07-08
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Providence St Joseph Medical Center Cancer Center — Burbank, California, United States
- City Of Hope — Duarte, California, United States
- University of California San Francisco Fresno Campus — Fresno, California, United States
- University of Southern California Norris Cancer Center — Los Angeles, California, United States
- Local Institution - 006 — Los Angeles, California, United States
- Local Institution - 050 — Orange, California, United States
- Sharp Memorial Hospital — San Diego, California, United States
- Stanford Cancer Center — Stanford, California, United States
- Innovative Clinical Research Institute — Whittier, California, United States
- Rocky Mountain Cancer Center — Denver, Colorado, United States
- Local Institution - 010 — Southington, Connecticut, United States
- George Washington University Cancer Center — Washington D.C., District of Columbia, United States
- Local Institution - 046 — Gainesville, Florida, United States
- Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
- Local Institution - 044 — Orlando, Florida, United States
- Northwestern University Medical Center — Chicago, Illinois, United States
- Loyola University Chicago — Maywood, Illinois, United States
- Cancer Care and Hematology Specialists of Chicagoland, P.C. - Niles, IL — Niles, Illinois, United States
- Local Institution - 013 — Indianapolis, Indiana, United States
- Franciscan St. Francis Health — Indianapolis, Indiana, United States
- Local Institution - 003 — Westwood, Kansas, United States
- Local Institution - 049 — Louisville, Kentucky, United States
- Local Institution - 058 — Louisville, Kentucky, United States
- Local Institution - 047 — New Orleans, Louisiana, United States
- Arizona Oncology Associates, P.C. — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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