Aplastic Anemia Clinical Trial
Official title:
Risk Stratification Directed Conditioning Regimen for Haploidentical HSCT in SAA
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.
Status | Recruiting |
Enrollment | 55 |
Est. completion date | March 30, 2022 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 55 Years |
Eligibility |
A:inclusion criteria 1. Patients diagnosed as acquired severe aplastic anemia(SAA) /very vSAA 2. patients with age 3-55 years 3. patients have no matched sibling donor 4. Patients have no matched unrelated donor 5. patients have no severe infection 6. Patients have no severe organ dysfunction 7. patients have risk factors of potential intolerance to previous condition regimen including BuCy(200mg/kg)and ATG 8. Consent form signed B. Exclusion criteria : 1. patients with congenital SAA/vSAA 2. patients with age< 3years or >55 years 3. patients with matched sibling donor 4. patients with matched URD 5. patients with severe infection 6. patients with severe organ dysfunction 7. pregnancy women 8. no Consent form signed |
Country | Name | City | State |
---|---|---|---|
China | Peking University Institute of Hematology,People's hospital Peking University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1 year cumulative incidence overall survival | Tne cumulative incidence of overall survival at 1 year post HSCT | 1 year post HSCT | |
Secondary | one month Transplantation related mortality | Tne cumulative incidence of transplantation related motality at 1 month post HSCT | 1 month post HSCT | |
Secondary | Engraftment | Tne cumulative incidence of engraftment at 1 moths post HSCT | 1 month post HSCT | |
Secondary | 0ne month regimen-related toxicity | Tne cumulative incidence of regimen related toxicity at 1 month post HSCT | 1 month post HSCT | |
Secondary | aGVHD | Tne cumulative incidence of acute GVHD at Day 100 post HSCT | 100 days post HSCT | |
Secondary | failure-free survival | The cumulative incidence of failure-free survival at 1year post HSCT | 1 year post HSCT |
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