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NCT06419634 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Bristol-Myers Squibb.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 105
- Enrollment target
- 15
- Study locations
NCT06419634 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is actively recruiting participants, run by Bristol-Myers Squibb. The registered enrollment target is 105 participants, roughly in line with the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target. The trial reports 15 study locations across 13 states.
The verdict
NCT06419634, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is actively recruiting participants, sponsored by Bristol-Myers Squibb.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 105 participants
- Enrollment target
- 15
- Study locations
Study Summary
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).
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG BMS-986497
Study Locations (15)
Massachusetts
- Local Institution - 0007 - Boston
- Massachusetts General Hospital - Boston
Other
- Local Institution - 0018 - Paris
- Local Institution - 0022 - Toulouse
Connecticut
- Yale-New Haven Hospital - New Haven
Illinois
- Northwestern Memorial Hospital - Chicago
Missouri
- Washington University School of Medicine, Siteman Cancer Center - St Louis
New Jersey
- John Theurer Cancer Center at Hackensack University Medical Center - Hackensack
New York
- Columbia University Irving Medical Center - New York
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2024-05-29 |
| Est. Completion | 2030-09-16 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06419634
The ClinicalTrials.gov registry entry for NCT06419634 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT06419634 reports 15 study locations spanning 13 distinct geographic areas - top geographies include Massachusetts, Other, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06419634 about?
NCT06419634 is a clinical study titled "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". 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 ...
What is the current status of trial NCT06419634?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2024-05-29. Estimated completion is 2030-09-16.
What conditions does trial NCT06419634 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome.
What interventions are being tested in trial NCT06419634?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), BMS-986497 (DRUG).
Who is sponsoring clinical trial NCT06419634?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06419634 being conducted?
This trial has 15 study locations across Connecticut, Illinois, Massachusetts, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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