Status:
UNKNOWN
Risk Stratification Directed Conditioning Regimen for Haploidentical HSCT in SAA
Lead Sponsor:
Peking University People's Hospital
Conditions:
Aplastic Anemia
Stem Cell Transplant Complications
Eligibility:
All Genders
3-55 years
Phase:
NA
Brief Summary
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 S...
Detailed Description
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 sample...
Eligibility Criteria
Inclusion
- A：inclusion criteria
- Patients diagnosed as acquired severe aplastic anemia(SAA) /very vSAA
- patients with age 3-55 years
- patients have no matched sibling donor
- Patients have no matched unrelated donor
- patients have no severe infection
- Patients have no severe organ dysfunction
- patients have risk factors of potential intolerance to previous condition regimen including BuCy(200mg/kg)and ATG
- Consent form signed
- B. Exclusion criteria ：
- patients with congenital SAA/vSAA
- patients with age\< 3years or \>55 years
- patients with matched sibling donor
- patients with matched URD
- patients with severe infection
- patients with severe organ dysfunction
- pregnancy women
- no Consent form signed
Exclusion
Key Trial Info
Start Date :
December 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2022
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03821987
Start Date
December 17 2018
End Date
March 30 2022
Last Update
March 10 2020
Active Locations (1)
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1
Peking University Institute of Hematology,People's hospital Peking University
Beijing, Beijing Municipality, China, 100044