The goal of this prospective, multicenter, single arm observational study is to evaluate the efficacy and safety of the BFCA regimen in ≥ 40 years old SAA patients undergoing haplo-HSCT.
Study Type
OBSERVATIONAL
Enrollment
64
busulfan 0.8 mg/kg/6h (days -8 to -7), fludarabine 30mg/m2/day (days -6 to -2), cyclophosphamide 25 mg/kg/day (days -5 to -2) and antithymocyte globulin(ATG) 2.5 mg/kg/day (days -5 to -2).
Peking Universtiy Peoples' Hospital
Beijing, Beijing Municipality, China
RECRUITINGFaliure free survival (FFS)
survival with a response to therapy after HSCT. Death, graft faliue and relapse were considered as treatment failure.
Time frame: From enrollment to 2 years post-HSCT
The probability of Overall survival
Overall survival was defined as the time from transplantation to death from any cause or to the last follow-up
Time frame: From enrollment to 2 years post-HSCT
Myeloid and platelet engraftment
Myeloid and platelet engraftment were defined as international criteria.
Time frame: 100 days post HSCT
The incidence of mixed chimerism
The mixed chimerism was defined as the presence of 5%-95% donor haematopoietic cells.
Time frame: 1 year post HSCT
The incidence of graft versus host disease(GVHD)
The severity of acute and chronic GVHD was evaluated according to standard criteria.
Time frame: 100 days post HSCT for aGvHD and 2 years post HSCT for cGvHD
Regimen related toxicity
The regimen related toxicity (RTT) was measured according to the Seattle Toxicity Criteria (Bearman et al, 1988).
Time frame: 100 days post HSCT
The incidence of Cytomegalovirus(CMV) and Epstein-Barr virus(EBV) reactivation
The incidence of CMV and EBV reactivation was defined as CMV and EBV viremia.
Time frame: 180 days post HSCT
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The incidence of Transplantation related mortality
Transplantation related mortality was defined as death without disease progression.
Time frame: 2 years post HSCT