VIALE-M: This phase III trial has been designed to evaluate the addition of two cancer treatments (venetoclax in combination with azacitidine) to standard care, compared with standard care on its' own as a maintenance therapy for adult's with acute myeloid leukaemia (AML)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)

Inclusion

• Diagnosis of newly diagnosed acute myeloid leukemia (AML).

• Participant meets the following disease activity criteria:

  • Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of intensive induction and consolidation chemotherapies.
  • Achieved first CR + CRi within 120 days of first dose of study drug or be no more than 75 days since last dose of intensive conventional chemotherapies.
  • AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
• Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.