Study of a New BFCA Conditioning Treatment Before Haploidentical Stem Cell Transplant in Severe Aplastic Anemia Patients Aged 40 to 60

What this Trial Is About

This research aims to assess the effectiveness and safety of a new BFCA conditioning regimen in patients aged 40 to 60 years with severe aplastic anemia undergoing haploidentical hematopoietic stem cell transplantation haplo-HSCT. The study is a prospective, multicenter, single-arm observational trial focused on this specific older patient group. It evaluates important outcomes such as failure-free survival and the incidence of complications associated with the transplant procedure. The BFCA conditioning regimen being studied includes busulfan, fludarabine, cyclophosphamide, and antithymocyte globulin given in a specific schedule before transplantation. The regimen is administered over several days prior to the stem cell transplant to prepare the body. This study observes patients receiving this regimen without comparison groups as it is a single-arm design conducted across multiple hospitals. Participants will be monitored from enrollment until two years after the transplant. Researchers will assess survival rates, blood cell recovery, graft-versus-host disease occurrence, viral reactivation, regimen-related toxicity, and transplant-related mortality. Follow-up evaluations include laboratory tests and clinical assessments at defined intervals up to two years to carefully track treatment effects and safety. The total participation duration extends from before transplant through long-term post-transplant monitoring.

A Novel Conditioning Regimen for Haplo-HSCT in Older Patients With SAA