SummaryThis study will have 2 parts: Part 1 (Dose Confirmation) and Part 2 (Randomisation). Part 1 seeks to determine the recommended Phase 3 dose (RP3D) of venetoclax in combination with azacitidine. In this part, participants will receiving various doses and dose regimens of venetoclax (orally) and azacitidine (via injection). Part 2 will further assess how safe and effective venetoclax with azacitidine is compared to Best Supportive Care. In Part 2, eligible participants will be randomly allocated to either Arm A or Arm B. In Part 2 Arm A, participants will receive venetoclax (orally) and azacitidine (via injection), in addition to Best Supportive Care. In Phase 2 Arm B, participants will receive Best Supportive Care as prescribed by their physician.
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A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine After Allogeneic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia (AML) (VIALE-T)