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NCT01757535 · ClinicalTrials.gov registry record · Phase 3
Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission
A Phase 3 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 472
- Enrollment target
NCT01757535: Completed Phase 3 study, sponsored by Celgene.
NCT01757535 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 472 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01757535, a Phase 3 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 472 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Overall survival was defined as time from randomization to death from any cause; participants surviving at the end of the follow-up period, or who withdraw consent, or who were lost to follow up were censored at the date last known alive.
Interventions
- DRUG Placebo
- DRUG Oral Azacitidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 472 participants |
| Start Date | 2013-04-24 |
| Est. Completion | 2024-06-18 |
| Phase | Phase 3 |
What the finished NCT01757535 record still lists
NCT01757535 is an interventional study that assigns participants to a tested intervention. The registered 472 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01757535 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01757535 about?
NCT01757535 is a clinical study titled "Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission". 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 ...
What is the current status of trial NCT01757535?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 472 participants. The study started on 2013-04-24. Estimated completion is 2024-06-18.
What interventions are being tested in trial NCT01757535?
The interventions under investigation include: Placebo (DRUG), Oral Azacitidine (DRUG).
Who is sponsoring clinical trial NCT01757535?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01757535's enrollment target sits among peer trials
472 811th of 2000 higher than 1,189 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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