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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
National Heart, Lung, and Blood Institute (NHLBI)
Astellas Pharma Inc.
Participants with FLT3/ITD AML in first morphologic complete remission (CR1) undergoing allogeneic hematopoietic stem cell transplant (HCT) will be randomized to receive gilteritinib or placebo 30 to 90 days after HCT for a two year period. Participants will be stratified according to: 1) conditioning regimen intensity (myeloablative vs. reduced intensity), 2) time from HCT to randomization (30-60 days vs. 61-90 days) and 3) presence or absence of minimal residual disease (MRD) from the most recent pre-registration bone marrow (BM) aspirate.