Eunice Wang, MD, Roswell Park Comprehensive Cancer Center, Buffalo, NY discusses the details of a Phase III trial (NCT02752035) of gilteritinib plus azacitidine (aza) versus aza alone in FLT3 mutated acute myeloid leukemia (AML) patients ineligible for standard chemotherapy. Gilteritinib, a FLT3 inhibitor, showed synergy with aza in preclinical investigations. Thus, the trial will randomize approximately 250 patients to gilteritinib plus aza or aza alone, and measure overall survival, remission rates, duration, and safety. Outcomes will also be stratified by age, cytogenetic risk, and FLT3 mutation. Enrollment into the randomization phase has begun. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.