NCT03821987

Risk Stratification Directed Conditioning Regimen for Haploidentical HSCT in SAA

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 55 Years
• Healthy volunteers: Not accepted

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 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.

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 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.

Conditions

• Aplastic Anemia
• Stem Cell Transplant Complications
• Engraft Failure

Interventions

Type	Name	Description
DRUG	Fludarabine	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.

Timeline

• Start date: 2018-12-17
• Primary completion: 2021-12-30
• Completion: 2022-03-30
• First posted: 2019-01-30
• Last updated: 2020-03-10

Locations

1 site across 1 country: China