NCT05168202

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

A Phase 1, Open-label, Dose Finding Study of CC-95251 Alone and in Combination With Antineoplastic Agents in Subjects With Acute Myeloid Leukemia and Myelodysplastic Syndromes

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	CC-95251	Specified dose on specified days
DRUG	Azacitidine	Specified dose on specified days
DRUG	Venetoclax	Specified dose on specified days

Timeline

• Start date: 2022-01-19
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2021-12-23
• Last updated: 2025-09-25
• Results posted: 2025-09-25

Locations

32 sites across 9 countries: United States, Australia, Canada, France, Italy, Norway, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study