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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05168202
Phase
PHASE1
Status
Terminated

Conditions

  • Leukemia, Myeloid, Acute
  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CC-95251 — DRUG
    Specified dose on specified days
  • Azacitidine — DRUG
    Specified dose on specified days
  • Venetoclax — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Jan 19, 2022
Status verified
Sep 2025
Primary completion
Jul 30, 2024
Completion
Jul 30, 2024

Study Design

Enrollment
56 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CC-95251 monotherapy
  • Experimental: CC-95251 + azacitidine
  • Experimental: CC-95251 + azacitidine + venetoclax

Primary Outcome Measure

Number of Participants With DLTs [ Time Frame: From Cycle 1 Day 1 to Cycle 1 Day 28 up to 42 post first dose of cycle 1 (upto 42 days) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Local Institution - 0030Los AngelesCalifornia90095-
Local Institution - 0031Palo AltoCalifornia94304-
Local Institution - 0047MiamiFlorida33136-
Local Institution - 0001HoustonTexas77030-

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