A Randomized Controlled Trial of Prophylactic Rituximab to Reduce Clinically Significant EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation

NCT07703657 — Not applicable, Not yet recruiting, 168 participants, Yang Donglin

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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

Registry	NCT07703657
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	168 (Estimated)
Sponsor	Yang Donglin (Other)
Conditions	Allogeneic Hematopoietic Stem Cell Transplantation, Epstein-Barr Virus Reactivation, Clinically Significant EBV DNAemia
Interventions	Rituximab (Arm A), Standard Post-Transplant Supportive Care (Drug, other)
Dates	start 2026-07-09 (estimated), primary completion 2027-07-09 (estimated), completion 2027-07-09 (estimated), first posted 2026-07-14, last updated 2026-07-14
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Prophylactic Rituximab Group	Active comparator	Drug: Rituximab (Arm A); Other: Standard Post-Transplant Supportive Care
Standard Care Control Group	Other	Other: Standard Post-Transplant Supportive Care

Rituximab (Arm A) (Drug): 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 (Other): Uniform routine allo-HSCT follow-up care including GVHD prophylaxis, letermovir CMV prophylaxis, blood transfusion, regular viral load monitoring.

+Outcome measures

Primary outcomes

Cumulative incidence of clinically significant EBV DNAemia within 180 days after allogeneic hematopoietic stem cell transplantation [From the date of allogeneic hematopoietic stem cell transplantation to Day 180 post-transplant]

Secondary outcomes

Incidence of any EBV DNAemia from randomization to Day +180 post-transplant [Randomization day to post-transplant Day 180]
Cumulative incidence of post-transplant lymphoproliferative disorder (PTLD) within 1 year [Randomization day to post-transplant Day 365]
1-year overall survival (OS) [Randomization day to post-transplant Day 365]

+Eligibility

Sex: All, ages: 16 Years to 65 Years

Inclusion Criteria:

\- Aged between 16 and 65 years old. Recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT). Clinically stable condition allowing administration of study intervention at post-transplant Day +21.

EBV-DNA quantitative test completed within 48 hours prior to randomization. Written informed consent signed by the participant or legal authorized representative.

Exclusion Criteria:

\- Presence of clinically significant EBV infection or meeting criteria for EBV preemptive therapy before randomization.

Prior rituximab administration during conditioning regimen. Confirmed or highly suspected post-transplant lymphoproliferative disorder (PTLD).

Severe anaphylactic history to rituximab or any excipients of the preparation. Active uncontrolled severe systemic infection. Active hepatitis B virus (HBV) infection without standardized antiviral prophylaxis or treatment.

Pregnant or breastfeeding female subjects. Subjects judged ineligible for participation by the investigator for any other reason.

+Locations (1)

Facility	City	Country	Status
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences	Tianjin	China