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Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission

Completed · Phase 3 · NCT01757535

Conditions: Leukemia, Myeloid, Acute

At a glance

Research payments reported, 2025
$68,780
U.S. investigators named
2
Sites paid
2
Planned or actual enrollment
472

About the trial

Sponsor
Celgene
Tested
Oral Azacitidine (drug), Placebo (drug)
Dates
Started 2013-04-24; completion 2024-06-18
Results posted
Yes

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…

From ClinicalTrials.gov, last updated 2025-07-08. Full record, eligibility and contacts (opens in a new tab)

Industry funding

E.r. Squibb & Sons, L.l.c. reported $68,780 in research payments for this study in 2025 (2 payments).

Products named: Onureg

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.