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A Randomized Controlled Trial of Prophylactic Rituximab to Reduce Clinically Significant EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation
Sponsor: Yang Donglin
Summary
This is a single-center, prospective, randomized, open-label clinical trial with blinded endpoint assessment for patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT). We aim to explore whether low-dose preventive rituximab can lower the risk of clinically significant Epstein-Barr virus (EBV) viremia within 180 days after transplantation. Patients aged 16-65 years who receive allo-HSCT and carry medium-to-high risks of EBV reactivation will be enrolled. All eligible participants will be randomly split into two groups at day +21 after transplant at a 1:1 ratio. Intervention group: Standard post-transplant supportive care plus two low doses of rituximab (100mg intravenous infusion on day +21 and day +28). Control group: Only standard routine post-transplant management without preventive rituximab. All participants will receive regular scheduled blood tests and outpatient follow-up visits up to 1 year after transplantation. We will monitor EBV viral load, cytomegalovirus (CMV) infection, graft-versus-host disease (GVHD), infection complications, immune function recovery, as well as long-term survival. We will also record all adverse reactions related to rituximab infusion, low immunoglobulin levels and other safety events. The main study outcome is the cumulative rate of clinically significant EBV viremia within 180 days post transplant. All endpoint judgments will be completed by independent researchers to reduce assessment bias. This trial hopes to confirm the safety and clinical value of low-dose rituximab prevention, and provide reliable clinical evidence for EBV infection prevention after hematopoietic stem cell transplantation.
Official title: A Prospective, Randomized, Controlled, Open-Label Clinical Trial With Blinded Endpoint Assessment of Prophylactic Rituximab for Reducing Clinically Significant EBV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation
Key Details
Gender
All
Age Range
16 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
168
Start Date
2026-07-09
Completion Date
2027-07-09
Last Updated
2026-07-14
Healthy Volunteers
No
Conditions
Interventions
Rituximab (Arm A)
Intervention Description Patients receive uniform standard allo-HSCT post-transplant care plus two low-dose prophylactic rituximab infusions: 100 mg IV on Day +21 and 100 mg IV on Day +28 after transplantation. Premedication is given before each infusion to avoid infusion reactions.
Standard Post-Transplant Supportive Care
Uniform routine allo-HSCT follow-up care including GVHD prophylaxis, letermovir CMV prophylaxis, blood transfusion, regular viral load monitoring.
Locations (1)
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China