A Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of Letermovir Prophylaxis Duration Guided by Dynamic Monitoring of Specific T-cells for Preventing Cytomegalovirus Infection in Adult Recipients of Allogeneic Hematopoietic Stem Cell Transplantation in China.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 12
- 主要终点
- Incidence of Clinically Significant CMV Infection (CS-CMVi)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of a personalized strategy for discontinuing Letermovir (a drug used to prevent Cytomegalovirus [CMV] infection) based on the recovery of the patient's own immune system.
Cytomegalovirus (CMV) is a common and serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Currently, Letermovir is typically given as a standard prevention for about 100 days post-transplant. However, some patients may recover their CMV-specific immunity earlier, while others may need longer protection.
In this study, researchers will use a dynamic monitoring technology (QuantiFERON-CMV) to detect the level of CMV-specific T-cells in patients. Participants will be randomly assigned to either the experimental group or the control group:
Experimental Group: Letermovir discontinuation will be guided by T-cell recovery. If the test shows that the patient's CMV-specific T-cells have recovered, Letermovir may be stopped earlier than the standard 100 days.
Control Group: Patients will receive the standard Letermovir prophylaxis for approximately 100 days, regardless of T-cell status.
The study aims to determine if this immune-guided strategy can effectively prevent CMV infection while potentially reducing the duration of medication and associated costs, without increasing the risk of CMV disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- •CMV serostatus of the recipient is positive (R+).
- •Aged 18 years or older.
- •Expected survival > 6 months.
- •Provision of signed informed consent.
排除标准
- •1.Active CMV infection or CMV disease at the time of screening.
- •2.Known hypersensitivity to Letermovir or its excipients.
- •3.Severe hepatic or renal impairment.
- •4.Pregnant or breastfeeding women.
研究组 & 干预措施
Active Comparator (Standard Prophylaxis Group)
干预措施: Standard Letermovir Prophylaxis (Drug)
Experimental (T-cell Guided Group)
干预措施: CMV-Specific T-cell Guided Letermovir Discontinuation (Drug)
结局指标
主要结局
Incidence of Clinically Significant CMV Infection (CS-CMVi)
时间窗: Through 200 days post-transplantation
The percentage of participants who develop clinically significant CMV infection, defined as CMV DNAemia requiring preemptive antiviral therapy (PET) according to institutional guidelines (e.g., two consecutive positive results or a single viral load ≥ 500 copies/mL) or the occurrence of CMV disease (e.g., CMV pneumonia, enteritis, or retinitis).
次要结局
- Duration of Letermovir Prophylaxis(Through 200 days post-transplantation)
研究者
WeiShi
Chief Physician
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology