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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.

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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

FieldValue
Enrollment Target 319 participants
Start Date 2015-12-30
Est. Completion 2024-03-25
Phase Phase 3

Sponsor

Celgene

308 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.