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 (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:

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:

218

Study ID:

NCT05168202

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 34 Locations for this study

See Locations Near You

UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)
Los Angeles California, 90095, United States More Info
Steven Tsai, Site 0030
Contact
626-862-5788
Stanford Cancer Center-Hematology
Palo Alto California, 94304, United States More Info
Gabriel Mannis, Site 0031
Contact
650-498-6000
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami Florida, 33136, United States More Info
Justin Watts, Site 0047
Contact
404-272-0609
University of Maryland
Baltimore Maryland, 21201, United States
UT Southwestern-Harold C. Simmons Cancer Center
Dallas Texas, 75235, United States
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 - 0027
Wollongong New South Wales, 2500, Australia More Info
Site 0027
Contact
Monash Health-Haematology Research
Clayton Victoria, 3168, Australia More Info
Jake Shortt, Site 0006
Contact
+61395944044
Local Institution - 0005
Heidelberg Victoria, 3084, Australia More Info
Site 0005
Contact
Local Institution - 0037
Melbourne Victoria, 3065, Australia More Info
Site 0037
Contact
Local Institution - 0019
Edmonton Alberta, T6G 2, Canada More Info
Site 0019
Contact
Local Institution - 0011
Vancouver British Columbia, V5Z 1, Canada More Info
Site 0011
Contact
Local Institution - 0010
Toronto Ontario, M5G 2, Canada More Info
Site 0010
Contact
Local Institution - 0038
Montreal Quebec, H3T 1, Canada More Info
Site 0038
Contact
Institut Paoli-Calmettes
Marseille , 13273, France More Info
Sylvain Garciaz, Site 0040
Contact
0491223333
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-hematology
Nantes , 44000, France More Info
Pierre Peterlin, Site 0029
Contact
33240083271
Hopital Du Haut-Leveque
Pessac , 33600, France More Info
arnaud Pigneux, Site 0020
Contact
+33670528816
Institut Claudius Regaud
Toulouse , 31059, France More Info
Christian Recher, Site 0023
Contact
33531156355
Gustave Roussy-DITEP
Villejuif , 94805, France More Info
Stephane De Botton, Site 0041
Contact
+33 1 42 11 40 79
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica
Meldola , 47014, Italy More Info
Giovanni Martinelli, Site 0018
Contact
+39 348 7704650
ASST Grande Ospedale Niguarda
Milan , 20162, Italy More Info
Roberto Cairoli, Site 0026
Contact
00390264444075
Humanitas-U.O di Oncologia medica ed Ematologia
Rozzano , 20089, Italy More Info
Matteo Giovanni Della Porta, Site 0017
Contact
0282247668
Local Institution - 0025
Bergen , 5021, Norway More Info
Site 0025
Contact
Local Institution - 0013
Oslo , N-002, Norway More Info
Site 0013
Contact
Local Institution - 0032
Badalona Barcelona [Barcelona], 08916, Spain More Info
Site 0032
Contact
Local Institution - 0039
Barcelona , 08041, Spain More Info
Site 0039
Contact
Local Institution - 0036
Madrid , 28007, Spain More Info
Site 0036
Contact
Local Institution - 0035
Salamanca , 37007, Spain More Info
Site 0035
Contact
Local Institution - 0028
Santander , 39008, Spain More Info
Site 0028
Contact
Local Institution - 0021
Gothenburg , 413 4, Sweden More Info
Site 0021
Contact
Local Institution - 0015
Lund , 22185, Sweden More Info
Site 0015
Contact
Local Institution - 0014
Stockholm , 141 8, Sweden More Info
Site 0014
Contact
Local Institution - 0044
Edinburgh Midlothian, EH4 2, United Kingdom More Info
Site 0044
Contact
Local Institution - 0050
Oxford Oxfordshire, OX3 7, United Kingdom More Info
Site 0050
Contact
Local Institution - 0048
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

218

Study ID:

NCT05168202

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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