Acute Myeloid Leukemia Clinical Trial

A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes

Summary

The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 alone and in combination with antineoplastic agents in participants with relapsed or refractory acute myeloid leukemia and relapsed or refractory and treatment-naive higher risk melodysplastic syndromes.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group Performance Status of 0 to 2

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 (ie, previously untreated) MDS as defined by the 2016 WHO Classification with intermediate, high or very high risk by IPSS-R

Exclusion Criteria:

Acute promyelocytic leukemia
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.

Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT05168202

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 37 Locations for this study

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Local Institution
Marina Del Rey California, 90292, United States More Info
Site 0030
Contact
Local Institution
Stanford California, 94305, United States More Info
Site 0031
Contact
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami Florida, 33136, United States More Info
Justin Watts, Site 0047
Contact
404-272-0609
Local Institution
Chicago Illinois, 60611, United States More Info
Site 0002
Contact
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
UT Southwestern-Harold C. Simmons Cancer Center
Dallas Texas, 75235, United States More Info
Yazan Madanat, Site 0051
Contact
214-648-7097
The University Of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Naval Daver, Site 0001
Contact
713-794-4392
Local Institution
Seattle Washington, 98104, United States More Info
Site 0046
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Local Institution
Wollongong New South Wales, 2500, Australia More Info
Site 0027
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Local Institution
Clayton Victoria, 3168, Australia More Info
Site 0006
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Local Institution
Fitzroy Victoria, 3065, Australia More Info
Site 0037
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Local Institution
Heidelberg Victoria, 3084, Australia More Info
Site 0005
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Local Institution - 0019
Edmonton Alberta, T6G 2, Canada More Info
Site 0019
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Local Institution
Vancouver British Columbia, V5Z 1, Canada More Info
Site 0011
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Local Institution
Toronto Ontario, M5G 2, Canada More Info
Site 0010
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Local Institution
Montreal Quebec, H3t1e, Canada More Info
Site 0038
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Local Institution
Odense , 5000, Denmark
Local Institution
Marseille , 13273, France More Info
Site 0040
Contact
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-hematology
Nantes , 44093, France More Info
Pierre Peterlin, Site 0029
Contact
+33240083271
Local Institution
Pessac , 33604, France More Info
Site 0020
Contact
Institut Claudius Regaud
Toulouse , 31100, France More Info
Christian Recher, Site 0023
Contact
+33531156355
Local Institution
Villejuif , 94805, France More Info
Site 0041
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Local Institution
Meldola , 47014, Italy More Info
Site 0018
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Local Institution - 0026
Milan , 20162, Italy More Info
Site 0026
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Local Institution
Rozzano , 20089, Italy More Info
Site 0017
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Local Institution
Bergen , 5012, Norway More Info
Site 0025
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Local Institution
Oslo , 0424, Norway More Info
Site 0013
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Local Institution - 0032
Badalona , 08916, Spain More Info
Site 0032
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Local Institution
Barcelona , 08049, Spain More Info
Site 0039
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Local Institution
Madrid , 28007, Spain More Info
Site 0036
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Local Institution - 0035
Salamanca , 37007, Spain More Info
Site 0035
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Local Institution
Santander , 39008, Spain More Info
Site 0028
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Local Institution
Goteborg , 41345, Sweden More Info
Site 0021
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Local Institution
Huddinge , 141 8, Sweden More Info
Site 0014
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Local Institution
Lund , 222 4, Sweden More Info
Site 0015
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Local Institution
Edinburgh , EH4 2, United Kingdom More Info
Site 0044
Contact
Local Institution
Oxford , OX3 7, United Kingdom More Info
Site 0048
Contact

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT05168202

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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