A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes
NCT ID: NCT05168202
Last Updated: 2025-09-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
56 participants
INTERVENTIONAL
2022-01-19
2024-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CC-95251 monotherapy
CC-95251
Specified dose on specified days
CC-95251 + azacitidine
CC-95251
Specified dose on specified days
Azacitidine
Specified dose on specified days
CC-95251 + azacitidine + venetoclax
Venetoclax
Specified dose on specified days
Interventions
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CC-95251
Specified dose on specified days
Azacitidine
Specified dose on specified days
Venetoclax
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
For Parts A \& B:
* Relapsed or refractory (R/R) acute myeloid leukemia (AML) as defined by the 2016 WHO Classification
* R/R myelodysplastic syndromes (MDS) as defined by the 2016 WHO Classification with intermediate, high or very high risk by Revised International Prognostic Scoring System (IPSS-R)
For Part C:
• Treatment-naïve (TN) (ie, previously untreated) MDS as defined by the 2016 WHO Classification with intermediate, high or very high risk by IPSS-R
For Part D:
• TN AML as defined by the 2016 WHO Classification, including secondary AML and therapy-related AML in participants who are ineligible (IE) for intensive chemotherapy (IC) and allogeneic hematopoietic stem cell transplant (HSCT)
Exclusion Criteria
* Immediately life-threatening, severe complications of leukemia such as disseminated/uncontrolled infection, uncontrolled bleeding, and/or uncontrolled disseminated intravascular coagulation
* Participants who have received prior treatment with a CD47 or SIRPα targeting agent
* Participant is on chronic systemic immunosuppressive therapy or corticosteroids
* Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks prior to starting study treatment, whichever is shorter (relapsed or refractory participants only).
* Any condition including, active or uncontrolled infection, or the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study
* Pregnant or nursing participants.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0030
Los Angeles, California, United States
Local Institution - 0031
Palo Alto, California, United States
Local Institution - 0047
Miami, Florida, United States
Local Institution - 0001
Houston, Texas, United States
Local Institution - 0027
Wollongong, New South Wales, Australia
Local Institution - 0006
Clayton, Victoria, Australia
Local Institution - 0005
Heidelberg, Victoria, Australia
Local Institution - 0037
Melbourne, Victoria, Australia
Local Institution - 0019
Edmonton, Alberta, Canada
Local Institution - 0011
Vancouver, British Columbia, Canada
Local Institution - 0010
Toronto, Ontario, Canada
Local Institution - 0038
Montreal, Quebec, Canada
Local Institution - 0040
Marseille, , France
Local Institution - 0029
Nantes, , France
Local Institution - 0020
Pessac, , France
Local Institution - 0023
Toulouse, , France
Local Institution - 0041
Villejuif, , France
Local Institution - 0018
Meldola, Emilia-Romagna, Italy
Local Institution - 0026
Milan, , Italy
Local Institution - 0017
Rozzano, , Italy
Local Institution - 0025
Bergen, , Norway
Local Institution - 0013
Oslo, , Norway
Local Institution - 0032
Badalona, Barcelona [Barcelona], Spain
Local Institution - 0039
Barcelona, , Spain
Local Institution - 0036
Madrid, , Spain
Local Institution - 0035
Salamanca, , Spain
Local Institution - 0028
Santander, , Spain
Local Institution - 0021
Gothenburg, , Sweden
Local Institution - 0015
Lund, , Sweden
Local Institution - 0014
Stockholm, , Sweden
Local Institution - 0044
Edinburgh, Midlothian, United Kingdom
Local Institution - 0050
Oxford, Oxfordshire, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2021-002799-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA059-001
Identifier Type: -
Identifier Source: org_study_id
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