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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/ITD AML
The main purpose of this study is to learn if it is safe and effective (works well) to treat participants who have FLT3/ITD AML with a study drug called gilteritinib (ASP2215) after transplant. Investigators want to know if this study drug works better than a placebo (pill that contains no drug, like a sugar pill) to stop the AML from coming back.
The primary objective is to compare relapse free survival (RFS) between participants with FLT3/ITD AML in CR1 who undergo HCT and are randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period. Secondary Objectives: 1. To determine the safety and tolerability of gilteritinib after HCT. 2. To compare overall survival (OS), non-relapse mortality (NRM) and event-free survival (EFS) (where events include relapse, death, stopping therapy and administration of donor lymphocyte infusion (DLI) or new therapy for suspicion of disease)in participants treated with gilteritinib as maintenance therapy after HCT compared to those treated with placebo. 3. To compare 6-month cumulative incidence of grade II-IV and III-IV aGVHD and 12-month and 24-moth cumulative incidence of mild, moderate, and severe GVHD in participants treated with gilteritinib as maintenance therapy after HCT compared to those treated with placebo. 4. To examine the effect of pre- and post transplant MRD on RFS and OS.