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

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.

Trial Description

Primary Outcome:

• Number of participants with a Dose-limiting toxicity (DLT)
• Incidence of adverse events (AEs)

• 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