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
Public ClinicalTrials.gov record NCT02577406. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation
Study identification
- NCT ID
- NCT02577406
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Celgene
- Industry
- Enrollment
- 319 participants
Conditions and interventions
Conditions
Interventions
- AG-221 Drug
- Azacitidine Drug
- BSC Other
- Intermediate-dose cytarabine (IDAC) Drug
- Low-dose cytarabine (LDAC) Drug
Drug · Other
Eligibility (public fields only)
- Age range
- 60 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 29, 2015
- Primary completion
- Mar 16, 2020
- Completion
- Mar 24, 2024
- Last update posted
- May 17, 2025
2015 – 2024
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 121 | Miami | Florida | 33136 | — |
| University of Florida Health Cancer Center at Orlando Health | Orlando | Florida | 32806 | — |
| Local Institution - 111 | Chicago | Illinois | 60637 | — |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Local Institution - 128 | New York | New York | 10029 | — |
| Strong Health System | Rochester | New York | 14642 | — |
| Montefiore Medical Center Albert Einstein Cancer Center | The Bronx | New York | 10467 | — |
| Duke University Medical Center | Durham | North Carolina | 27705 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Local Institution - 104 | Greenville | South Carolina | 29615 | — |
| Baylor Sammons Cancer Center | Dallas | Texas | 75246 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 81 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02577406, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 17, 2025 · Synced May 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02577406 live on ClinicalTrials.gov.