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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Donglin Yang
- 电话号码：02223608592
- 邮箱：yangdonglin@ihcams.ac.cn
学习地点
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Tianjin、中国
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
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接触：
- Donglin Yang
- 电话号码：02223608592
- 邮箱：yangdonglin@ihcams.ac.cn
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：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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其他：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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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Cumulative incidence of clinically significant EBV DNAemia within 180 days after allogeneic hematopoietic stem cell transplantation
大体时间：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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次要结果测量
结果测量 |
大体时间 |
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Incidence of any EBV DNAemia from randomization to Day +180 post-transplant
大体时间：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
大体时间：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)
大体时间：Randomization day to post-transplant Day 365
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Randomization day to post-transplant Day 365
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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