About this trial
The TBI-containing reduced-dose conditioning regimen was used to treat elderly patients with aplastic anemia who received hematopoietic stem cell transplantation. The overall survival rate, GVHD-free survival rate, all-cause mortality,et al were studied. The modified conditioning regimen included TBI 2Gy, -7d, busulfan 3.2mg / kg-6d ; fludarabine 30mg / m2 / d-5 \~ -1d ; cyclophosphamide 25-30mg / kg / d-5 \~ -2d ; ATG ( rabbit ) 2 mg / kg / d-5 \~ -1d.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
( 1 ) Diagnosis of aplastic anemia, including very severe aplastic anemia, severe aplastic anemia, chronic aplastic anemia and hepatitis-associated aplastic anemia.
Disqualifiers
( 1 ) Patients who underwent more than one time of transplantation before enrollment ; ( 2 ) Uncontrolled infection, mechanical ventilation or hemodynamic instability at the time of enrollment ; ( 3 ) Diagnosis of clinically significant severe liver dysfunction ( defined as Child-Pugh C grade ) within 5 days before enrollment ; or within 5 days before enrollment, AST or ALT was 5 times higher than the upper limit of normal, or serum total bilirubin was 2 times higher than the upper limit of normal ; ( 4 ) End-stage renal insufficiency was diagnosed within 5 days before enrollment, and creatinine clearance rate was less than 10ML / min.
Trial design
Single group
Treatments tested in this trial
reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating elderly patients with aplastic anemia
Drugreduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating elderly patients with aplastic anemia
Treatment groups
Trial outcomes
Primary outcomes
overall survival
2-year overall survival
Locations
Sponsors and contacts
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