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

Official Title

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


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.

Trial Description

Primary Outcome:

  • Number of participants with a Dose-limiting toxicity (DLT)
  • Incidence of adverse events (AEs)
Secondary Outcome:
  • Complete remission rate (CRR) for acute myeloid leukemia (AML) according to the modified European Leukemia Net (ELN) response criteria
  • Overall response rate (ORR) for AML
  • CRR for myelodysplastic syndromes (MDS) according to the modified International Working Group (IWG) Response Criteria
  • ORR for MDS
  • Duration of remission
  • Duration of response
  • Stable disease rate is the rate of MDS participants whose best response is stable disease
  • Relapse-free survival
  • Event-free survival
  • Progression-free survival
  • Time to remission/response
  • Transfusion independence
  • Time to AML transformation for MDS participants
  • Overall survival (OS) rates at 6 months
  • OS rates at 12 months
  • Maximum plasma concentration of drug (Cmax)
  • Minimum serum concentration (Cmin)
  • Trough observed serum concentration (Ctrough)
  • Presence of anti-CC-95251 antibodies (ADAs) using a validated electrochemiluminescence (ECL) assay
  • Frequency of ADAs using a validated ECL assay

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society