The haplotype HSCT system including Bu(0.8mg/kg Q6hx2d)CTX(50mg/kgx4d)rATG(2.5mg/kgx4d) , established in Institute of Hematology of Peking University ,has been evaluated to be effective for acquired SAA.But some patients with high risk factors may not tolerate CTX 200mg/kg,alternative conditioning regimen including Bu/Fludarabine/dercreased CTX was studied in this trial.
Patients enrolled in this study would receive Bu (IV)0.8mg/kg Q6hx2d,Fludarabine 30mg/m2x5d ,CTX(cyclophosphamide) 25mg/kg/dx4d,rATG (thymoglobulin,Sang Stat,France) 2.5mg/kg/dx4d. BM or Blood samples from patients were obtained to assess engraftment and chimerism after HSCT. The time point that investigators monitor BM or blood samples at 1 month,2 months, 3 months,6 months, 9 months and 1year,2years,3years 5 years after HSCT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Patients enrolled in this study would receive Bu (IV)0.8mg/kg Q6hx2d,Fludarabine 30mg/m2x5d ,CTX (cyclophosphamide) 25mg/kg/dx4d,rATG (thymoglobulin,Sang Stat,France) 2.5mg/kg/dx4d.
Peking University Institute of Hematology,People's hospital Peking University
Beijing, Beijing Municipality, China
RECRUITING1 year cumulative incidence overall survival
Tne cumulative incidence of overall survival at 1 year post HSCT
Time frame: 1 year post HSCT
one month Transplantation related mortality
Tne cumulative incidence of transplantation related motality at 1 month post HSCT
Time frame: 1 month post HSCT
Engraftment
Tne cumulative incidence of engraftment at 1 moths post HSCT
Time frame: 1 month post HSCT
0ne month regimen-related toxicity
Tne cumulative incidence of regimen related toxicity at 1 month post HSCT
Time frame: 1 month post HSCT
aGVHD
Tne cumulative incidence of acute GVHD at Day 100 post HSCT
Time frame: 100 days post HSCT
failure-free survival
The cumulative incidence of failure-free survival at 1year post HSCT
Time frame: 1 year post HSCT
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