A Randomized Controlled Trial of Prophylactic Rituximab to Reduce Clinically Significant EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation
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
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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Donglin Yang
- 전화번호: 02223608592
- 이메일: yangdonglin@ihcams.ac.cn
연구 장소
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Tianjin, 중국
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
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연락하다:
- Donglin Yang
- 전화번호: 02223608592
- 이메일: yangdonglin@ihcams.ac.cn
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Prophylactic Rituximab Group
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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.
Uniform routine allo-HSCT follow-up care including GVHD prophylaxis, letermovir CMV prophylaxis, blood transfusion, regular viral load monitoring.
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다른: Standard Care Control Group
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Uniform routine allo-HSCT follow-up care including GVHD prophylaxis, letermovir CMV prophylaxis, blood transfusion, regular viral load monitoring.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Cumulative incidence of clinically significant EBV DNAemia within 180 days after allogeneic hematopoietic stem cell transplantation
기간: From the date of allogeneic hematopoietic stem cell transplantation to Day 180 post-transplant
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From the date of allogeneic hematopoietic stem cell transplantation to Day 180 post-transplant
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2차 결과 측정
결과 측정 |
기간 |
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Incidence of any EBV DNAemia from randomization to Day +180 post-transplant
기간: Randomization day to post-transplant Day 180
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Randomization day to post-transplant Day 180
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Cumulative incidence of post-transplant lymphoproliferative disorder (PTLD) within 1 year
기간: Randomization day to post-transplant Day 365
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Randomization day to post-transplant Day 365
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1-year overall survival (OS)
기간: Randomization day to post-transplant Day 365
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Randomization day to post-transplant Day 365
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IIT2026080-EC-1
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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