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CC-95251 for Leukemia

Phase 1
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
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)
Must not have
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)
Acute promyelocytic leukemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called CC-95251 to see if it can help treat patients with difficult-to-treat blood cancers. The study will check if the drug is safe and effective when used alone or with other cancer treatments.

Who is the study for?
This trial is for adults with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), as well as treatment-naive MDS at higher risk. Participants should be able to perform daily activities with minimal assistance. They can't join if they have life-threatening complications, prior treatments with similar drugs, uncontrolled infections, recent cancer treatments, are on immunosuppressants, or are pregnant/nursing.
What is being tested?
The study tests the safety and effectiveness of CC-95251 alone and combined with other cancer drugs in treating AML and MDS. It's looking at how well patients respond to the treatment and what side effects occur when using CC-95251 with Azacitidine and Venetoclax.
What are the potential side effects?
Possible side effects include reactions related to the immune system such as fever or chills, fatigue from anemia or low blood counts due to bone marrow suppression by Azacitidine/Venetoclax, bleeding issues from low platelets count, infection risks due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a type of leukemia that can't be treated with intense chemo or stem cell transplant.
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My condition is a type of blood disorder classified as intermediate, high, or very high risk.
Select...
I can take care of myself and am up and about more than half of my waking hours.
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My condition is relapsed or refractory acute myeloid leukemia.
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My MDS is untreated and is intermediate, high, or very high risk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had cancer treatments or experimental drugs within the last 4 weeks or 5 half-lives, whichever is shorter.
Select...
I have been diagnosed with acute promyelocytic leukemia.
Select...
I have been treated with a CD47 or SIRPα targeting agent before.
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I do not have severe, life-threatening complications from leukemia.
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I am on long-term medication to suppress my immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: CC-95251 monotherapyExperimental Treatment1 Intervention
Group II: CC-95251 + azacitidine + venetoclaxExperimental Treatment1 Intervention
Group III: CC-95251 + azacitidineExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-95251
2022
Completed Phase 1
~60
Azacitidine
2012
Completed Phase 3
~1440
Venetoclax
2019
Completed Phase 3
~2240

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Myelodysplastic Syndrome (MDS) include DNA methyltransferase inhibitors like azacitidine and decitabine, which work by reactivating tumor suppressor genes through hypomethylation of DNA. Lenalidomide, particularly effective in patients with del(5q) MDS, modulates the immune system and promotes the repopulation of normal bone marrow cells. Targeted therapies and immunotherapies, such as those being studied with CC-95251, aim to enhance the body's immune response against malignant cells or directly target specific pathways involved in the disease. Understanding these mechanisms is crucial for MDS patients as it helps in selecting the most effective treatment, predicting responses, and managing potential side effects.
SOHO State of the Art and Next Questions: Management of Myelodysplastic Syndromes With Deletion 5q.Lenalidomide as a disease-modifying agent in patients with del(5q) myelodysplastic syndromes: linking mechanism of action to clinical outcomes.Combination therapy with DNA methyltransferase inhibitors in hematologic malignancies.

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,691 Previous Clinical Trials
4,097,532 Total Patients Enrolled

Media Library

CC-95251 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05168202 — Phase 1
Myelodysplastic Syndrome Research Study Groups: CC-95251 monotherapy, CC-95251 + azacitidine, CC-95251 + azacitidine + venetoclax
Myelodysplastic Syndrome Clinical Trial 2023: CC-95251 Highlights & Side Effects. Trial Name: NCT05168202 — Phase 1
CC-95251 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05168202 — Phase 1
~15 spots leftby Dec 2025