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NCT02577406 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation
A Phase 3 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 319
- Enrollment target
NCT02577406: Completed Phase 3 study, sponsored by Celgene.
NCT02577406 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 319 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02577406, a Phase 3 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 319 participants
- Enrollment target
Study Summary
This is an international, multicenter, open-label, randomized, Phase 3 study comparing the efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation.
Primary Outcome
The time between randomization and death from any cause. Participants who drop-out or are alive at the end of trial will have their OS times censored at the time of last contact, as appropriate.
Interventions
- DRUG Azacitidine
- DRUG AG-221
- OTHER BSC
- DRUG Low-dose cytarabine (LDAC)
- DRUG Intermediate-dose cytarabine (IDAC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 319 participants |
| Start Date | 2015-12-30 |
| Est. Completion | 2024-03-25 |
| Phase | Phase 3 |
What the finished NCT02577406 record still lists
NCT02577406 is an interventional study that assigns participants to a tested intervention. The registered 319 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 (59% lower).
The record links to 0 conditions, and to 5 interventions - of which Azacitidine is the first listed.
NCT02577406 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02577406 about?
NCT02577406 is a clinical study titled "An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation". This is an international, multicenter, open-label, randomized, Phase 3 study comparing the efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or third-line AML therapy and posi...
What is the current status of trial NCT02577406?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 319 participants. The study started on 2015-12-30. Estimated completion is 2024-03-25.
What interventions are being tested in trial NCT02577406?
The interventions under investigation include: Azacitidine (DRUG), AG-221 (DRUG), BSC (OTHER), Low-dose cytarabine (LDAC) (DRUG), Intermediate-dose cytarabine (IDAC) (DRUG).
Who is sponsoring clinical trial NCT02577406?
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 NCT02577406's enrollment target sits among peer trials
319 1087th of 2000 higher than 914 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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