A novel reduce toxity myeloablative conditioning regimen f-BMT improves efficacy and safety of allogeneic hematopoietic stem cell transplantation in patients with transfusion-dependent thalassemia: A multicenter clinical trial
Abstract
Background Conditioning regimens are crucial in allogeneic hematopoietic stem cell transplantation (allo-HSCT), especially for older patients (≥7 years) with transfusion-dependent thalassemia (TDT) recieving haplo indentical transplantation (HID). The development of low-toxicity conditioning yet myeloablative regimens is essential to address the dual challenges of high graft rejection rates and transplant-related mortality.
Objective This study aimed to evaluate the efficacy and safety of the F-BMT conditionig regimen in improving allo-HSCT outcomes for TDT patients, especially for older patients with HID transplantation .
Methods This prospective, multicenter clinical trial was conducted at 923rd Hospital of the Joint Logistics Support Force, the First Affiliated Hospital of Guilin Medical University, and the Eighth Affiliated Hospital of Southern Medical University.Patients with TDT aged 3–25 years were enrolled. The F-BMT regimen included fludarabine 30 mg/m² (days –7 to –2), busulfan 130 mg/m² (day –7), thiotepa 250 mg/m² (day –5), melphalan 100 mg/m² (day –3). For graft versus host disease (GVHD) prentation, porcine anti-human lymphocyte immunoglobulin (p-ALG) (25 mg/kg) or antithymocyte globulin (r-ATG) (2.5 mg/kg ) on days –1, cyclophosphamide 25 mg/kg (days +3 and +4)，methotrexate 5 mg/m² (day +5), cyclosporine (initiated on day +5, continued for 12 months). For HID donors, additional agents were administered: p-ALG (25 mg/kg ) or r-ATG (2 mg/kg) on day day +5,…
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