A Randomized Phase 2/3 Study Evaluating the Safety and Efficacy of Pivekimab Sunirine (PVEK) in Combination with Venetoclax and Azacitidine in Adult Subjects with Newly Diagnosed Acute Myeloid Leukemia (AML) Ineligible to Receive Intensive Chemotherapy

Condition studied

Acute Myeloid Leukemia

Investigational medicinal product(s)

Eligibility

Primary endpoint

Phase 2: Complete remission (CR), Phase 3: Complete remission (CR), Phase 3: Overall Survival (OS), Number of Participants with Adverse Events (AEs)

Endpoint detail

Phase 2 and Phase 3: Composite Response, Phase 2 and Phase 3: Duration of CR (DoCR), Phase 2: Change from baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORCT QLQ-C30) domains, Phase 3: Percentage of Participants with Transfusion Independence, Phase 3: Conversion from baseline transfusion dependence to post-baseline transfusion independence, Phase 3: Change from baseline in the EORCT QLQ-C30 physical functioning domains, Phase 3: Change from baseline in the remaining EORCT QLQ-C30 domains, Phase 3: Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Utility Index and Visual Analog Scale (VAS) scores, Phase 3: Change from Baseline to the responses to FACT GP5