Thiotepa Combined With Busulfan and Fludarabine Conditioning Regimen for Haploidentical Hematopoietic Stem Cell Transplantation in Elderly Patients With High-Risk Acute Myeloid Leukemia

PHASE2RecruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

April 1, 2028

Study Completion Date

April 1, 2029

Conditions
Acute Myeloid Leukemia (AML)High Risk Acute Myeloid Leukemia(AML)Relapsed/Refractory Acute Myeloid Leukemia (AML)
Interventions
DRUG

Thiotepa ;busulfan;fludarabine

Eligible patients will receive the following conditioning regimen: thiotepa 5 mg/kg/day on Days -10 to -9; busulfan 3.2 mg/kg/day on Days -8 to -6; fludarabine 30 mg/m²/day on Days -6 to -2; and rabbit anti-thymocyte globulin (rATG) 1.5-2.5 mg/kg/day on Days -5 to -2. Hematopoietic stem cell infusion will be performed on Day 0. Graft-versus-host disease (GVHD) prophylaxis will include cyclosporine A (CsA), mycophenolate mofetil (MMF), and methotrexate (MTX).

Trial Locations (1)

100044

RECRUITING

Peking University People's Hospital, Beijing

All Listed Sponsors
lead

Peking University People's Hospital

OTHER