MAC vs RIC for Transplantation in FLT3-ITD-Mutated AML Guided by UHS-NGS MRD ( FLT3 - MAC vs RIC )

This is a multicenter, open-label, 1:1 randomized non-inferiority trial with stratification. The study will enroll patients aged 18-60 years with FLT3-ITD-mutated acute myeloid leukemia (AML) who are in first complete remission (CR1) and have no detectable FLT3-ITD measurable residual disease (MRD) by polymerase chain reaction-next-generation sequencing (PCR-NGS) before allogeneic hematopoietic stem cell transplantation (allo-HSCT). Eligible patients will be randomly assigned to receive either reduced-intensity conditioning (RIC) or myeloablative conditioning (MAC) before allo-HSCT. All patients will receive FLT3 inhibitor maintenance therapy after transplantation. The primary objective is to determine whether RIC is non-inferior to MAC in terms of 2-year relapse-free survival (RFS), defined as the time from transplantation to relapse or death from any cause. Secondary objectives include comparisons of overall survival (OS), non-relapse mortality (NRM), cumulative incidence of relapse, and graft-versus-host disease (GVHD)-free, relapse-free survival (GRFS) between the two conditioning groups.