A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy (NCT02677922)
A Phase 1b/2 Open-Label, Randomized Study of 2 Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine: Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus SC Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia Harboring an IDH1 or an IDH2 Mutation, Respectively, Who Are Not Candidates to Receive Intensive Induction Chemotherapy
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study are 1. to determine the recommended combination dose of AG-120 and AG-221 separately when administered with azacitidine and, 2. to investigate the safety, tolerability, and efficacy of the combinations of AG-120 with azacitidine and AG-221 with azacitidine versus with azacitidine alone in participants with acute myeloid leukemia (AML) with the isocitrate dehydrogenase (IDH) enzyme isoforms 1 or 2 mutations, respectively.
Who can join: Review the eligibility criteria below.
Location: Local Institution - 105 — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (49 Sites)
Showing the first 25 of 49 sites.
- Local Institution - 105 — Duarte, California
- Local Institution - 107 — New Haven, Connecticut
- Local Institution - 108 — Chicago, Illinois
- Local Institution - 103 — Chicago, Illinois
- Local Institution - 102 — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Local Institution - 902 — Boston, Massachusetts
- Local Institution - 106 — New York, New York
- Local Institution - 110 — Dallas, Texas
- Local Institution - 178 — Adelaide, South Australia
- Local Institution - 175 — Melbourne,
- Local Institution - 177 — Perth,
- Local Institution - UNK-121 — Yvoir,
- Local Institution - 125 — Toronto, Ontario
- Local Institution - 205 — Lille,
- Local Institution - 206 — Marseille,
- Local Institution - 200 — Paris,
- Local Institution - 204 — Pessac,
- Local Institution - 202 — Pierre-Bénite,
- Local Institution - 203 — Toulouse,
- Local Institution - 201 — Villejuif,
- Local Institution - 227 — Berlin,
- Local Institution - 230 — Dresden,
- Local Institution - 225 — Ulm,
- Local Institution - 253 — Bologna, Emilia-Romagna,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.