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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 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 319 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02577406
The ClinicalTrials.gov registry entry for NCT02577406 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 319 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 5 interventions - of which Azacitidine is the first listed.
NCT02577406 reports 0 study locations.
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.
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