Actively Recruiting
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
Led by Bristol-Myers Squibb · Updated on 2026-04-08
105
Participants Needed
16
Research Sites
328 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
- Detectable levels of cluster of differentiation 33 (CD33) expression
- Failed alternative therapies with established benefit
- Eastern Cooperative Oncology Group (ECOG) performance status C2 and adequate organ function
You will not qualify if you...
- Acute Promyelocytic Leukemia
- Clinically active central nervous system leukemia
- Active malignant solid tumor
- Pregnant or breastfeeding
- Other protocol-defined inclusion/exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
3
Local Institution - 0007
Boston, Massachusetts, United States, 02114
Withdrawn
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
Washington University School of Medicine, Siteman Cancer Center
St Louis, Missouri, United States, 63108
Actively Recruiting
6
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
7
Columbia University Irving Medical Center
New York, New York, United States, 10032
Withdrawn
8
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
9
Local Institution - 0009
Fairfax, Virginia, United States, 22031
Withdrawn
10
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
11
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
12
Local Institution - 0017
Marseille, Bouches-du-Rhône, France, 13273
Not Yet Recruiting
13
Local Institution - 0018
Paris, France, 75010
Not Yet Recruiting
14
Local Institution - 0022
Toulouse, France, 31100
Not Yet Recruiting
15
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], Spain, 08036
Actively Recruiting
16
Hospital Universitario Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
F
First line of the email MUST contain NCT # and Site #.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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