Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome (NCT06419634)
Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double Combination With Azacitidine and in Triple Combination With Azacitidine and Venetoclax in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to assess the safety, tolerability, drug levels, drug efficacy and determine the recommended dose of BMS-986497 as a monotherapy, in double combination with Azacitidine and in triple combination with Azacitidine and Venetoclax in participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
Who can join: Review the eligibility criteria below.
Location: Yale-New Haven Hospital — New Haven, Connecticut
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 (16 Sites)
- Yale-New Haven Hospital — New Haven, Connecticut
- Northwestern Memorial Hospital — Chicago, Illinois
- Local Institution - 0007 — Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts
- Washington University School of Medicine, Siteman Cancer Center — St Louis, Missouri
- John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey
- Columbia University Irving Medical Center — New York, New York
- University of Texas MD Anderson Cancer Center — Houston, Texas
- Local Institution - 0009 — Fairfax, Virginia
- Princess Margaret Cancer Centre — Toronto, Ontario
- Jewish General Hospital — Montreal, Quebec
- Local Institution - 0017 — Marseille, Bouches-du-Rhône
- Local Institution - 0018 — Paris,
- Local Institution - 0022 — Toulouse,
- Hospital Clínic de Barcelona — Barcelona, Catalunya [Cataluña]
- Hospital Universitario Virgen Del Rocio — Seville,
📞 Contact the Study Coordinator
Phone: (855) 907-3286
Email: Clinical.Trials@bms.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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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- Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy — Little Rock, Arkansas
- Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia — Burbank, California
- A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies — Duarte, California
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Explore by condition: All Acute Myeloid Leukemia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.