GVHD Prophylaxis by Addition of CD20 Monoclonal Antibody to the Conditioning Regimen in SAA With Treatment of Allo-HSCT
Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
Objectives 2.1 Primary objectives
1) To observe and compare incidence and severity of aGVHD and cGVHD between the two arms
within 2 years after transplantation.
2) To observe and compare the engraftment rate between the two arms. 3) To observe and
compare the incidence of infections between the two arms. 2.2 Secondary objectives
1. To conduct pharmacogenomic assay in CD20 arm(treatment arm) before conditioning and
monitor plasma concentration of CD20 dynamically（7d、14d、28d、56d、91d）.
2. To monitor levels of B cells in peripheral blood dynamically
(+90d、+180d、+270d、+360d、+450d、+540d、+630d、+720d) in all patients.
3. To observe and compare the incidence of PTLD between the two arms.
4. To observe and compare immunoglobulin levels after transplantation in all patients.
5. To evaluate transplant-related mortality.
6. To evaluate the effect on hematopoietic reconstruction.
Phase:
Phase 2
Details
Lead Sponsor:
The First Affiliated Hospital of Soochow University