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MAC vs RIC for Transplantation in FLT3-ITD-Mutated AML Guided by UHS-NGS MRD ( FLT3 - MAC vs RIC )
Sponsor: First Affiliated Hospital of Zhejiang University
Summary
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.
Official title: A Prospective, Multicenter, Open-label Randomized Trial Comparing Myeloablative vs Reduced-intensity Conditioning for Transplantation in FLT3-ITD-Mutated AML Guided by UHS-NGS MRD
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
310
Start Date
2026-11-01
Completion Date
2029-09-30
Last Updated
2026-10-29
Healthy Volunteers
No
Interventions
RIC
1. Flu/Bu2 or Flu/Bu3: The total dose of fludarabine is 120-180 mg/m², and the total intravenous dose of busulfan is 6.4-9.6 mg/kg. 2. Flu/Mel: The total dose of fludarabine is 120-180 mg/m², and the total dose of melphalan is 120-150 mg/m². For the purposes of this study, Flu/Bu3 is included in the RIC group as a protocol-specified reduced-toxicity conditioning regimen.
MAC
1. Bu4/Cy2: The total intravenous dose of busulfan is 12.8 mg/kg, and the total dose of cyclophosphamide is 120 mg/kg. 2. Bu4/Flu: The total intravenous dose of busulfan is 12.8 mg/kg, and the total dose of fludarabine is 120-180 mg/m². 3. Modified Bu/Cy regimen: For patients undergoing haploidentical transplantation, a modified Bu/Cy-based regimen incorporating cytarabine (Ara-C) could be used according to institutional protocols. The regimen consisted of Ara-C at a total dose of 4-8 g/m², intravenous busulfan at a total dose of 9.6 mg/kg, and cyclophosphamide at a total dose of 3.6 g/m².
Locations (1)
The First Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang, Zhejiang, China