“A Safety and Efficacy Study of Oral Venetoclax Tablets and Injectable Azacitidine Versus Best Supportive Care as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy to Evaluate Improvement in Relapse-Free Survival”
The main objective of this study is to evaluate safety and efficacy of venetoclax in combination with azacitidine (AZA) and best supportive care (BSC) compared to BSC as maintenance therapy in adult participants with acute myeloid leukemia (AML) in first remission after conventional chemotherapy. This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose of venetoclax in combination with AZA. Part 2 will be the randomization portion to evaluate if venetoclax in combination with AZA as maintenance therapy improves RFS comparing to BSC. Part 2 begins after Part 1 is completed. During this study, participants will receive venetoclax and azacitidine or best supportive care for approximately 2 years with study visits varying from 1-5 per month.
Drug - Venetoclax
Drug - Azacitidine
Subcutaneous (SC) or intravenous (IV) injection
Best Supportive Care (BSC)
BSC is the best supportive care and expectant management according to institutional standards excluding AML directed therapy. BSC will be determined for each participant by the investigator.
Randomized, Open-label, 2-Arm, Multicenter, Phase 3 Study of Venetoclax and Azacitidine Versus Best Supportive Care as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)