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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 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 472 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01757535
The ClinicalTrials.gov registry entry for NCT01757535 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 472 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01757535 reports 0 study locations.
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.
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