A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy

This is a randomized, open-label, multicenter, Phase 2 trial to evaluate the efficacy, safety, and pharmacodynamics of cusatuzumab in combination with venetoclax and azacitidine (VAC) compared to venetoclax and azacitidine (VA) in persons with newly diagnosed AML who are deemed ineligible for intensive chemotherapy. The trial will be conducted in 2 Parts. Part A will seek to randomize approximately 120 participants 2:1 to receive VAC or VA. Randomized participants will be stratified based on AML risk features (adverse, intermediate, and favorable risk). Part B will seek to include approximately 20 participants to receive an alternative dose of cusatuzumab in combination with VA in a non-randomized fashion. Parts A and B will utilize the same eligibility criteria, study assessments, and treatment guidelines and procedures unless otherwise specified. Potential participants will be considered ineligible for intensive chemotherapy and, therefore, eligible for the study, if they meet the trial eligibility criteria and provide informed consent. Participants will undergo a diagnostic bone marrow biopsy and aspirate collected for pathology review, cytogenetics, fluorescence in situ hybridization (FISH), and polymerase chain reaction (PCR) analysis and other studies for confirmation of a diagnosis of AML and to define whether participants have adverse, intermediate, or favorable AML risk features.