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)(M19-063)
Objective
Primary Objective To determine the recommended Phase 3 dose of venetoclax in combination with azacitidine in AML patients when given as maintenance therapy following allogeneic stem cell transplantation.
Part 2 Objectives Primary Objective: To determine the efficacy of venetoclax in combination with azacitidine to improve RFS in AML patients compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation.
Secondary Objectives: To confirm the safety of venetoclax in combination with azacitidine after allogeneic transplantation in subjects diagnosed with AML.
To determine the efficacy of venetoclax in combination with azacitidine as determined by overall survival. To determine the effect of venetoclax in combination with azacitidine on the frequency and severity of GvHD. To determine the effect of venetoclax in combination with azacitidine on Quality of Life (QoL). To determine the effect of Venetoclax in combination with azacitidine on minimal residual disease levels.
