Letermovir Prophylaxis Duration Guided by CMV-Specific T-cell Monitoring After Allo-HSCT.
Key facts
- Where
- Beijing, Hohhot, Jingzhou, Nanchang, Shijiazhuang, Wenzhou, Wuhan, and Zhengzhou, ChinaSee the 12 sites
- Phase
- Phase 4
Where in China
- Chinese PLA General HospitalBeijing, ChinaContact: Fei LiNot yet recruiting
- The Affiliated Hospital of Inner Mongolia Medical UniversityHohhot, ChinaContact: Da GaoNot yet recruiting
- Jingzhou Central HospitalJingzhou, ChinaContact: Yuanyan TangNot yet recruiting
- Jingzhou First People's HospitalJingzhou, ChinaContact: Jie TanNot yet recruiting
- The First Affiliated Hospital of NanChang UniversityNanchang, ChinaContact: Xianbao HuangNot yet recruiting
- The Second Hospital of Hebei Medical UniversityShijiazhuang, ChinaContact: Fuxu WangNot yet recruiting
- The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaContact: Lan Sun SunNot yet recruiting
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaContact: Yang CaoNot yet recruiting
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaContact: Wei Shi, M.D.Taking people
- Zhongnan Hospital of Wuhan UniversityWuhan, ChinaContact: Fei ChenNot yet recruiting
- Henan Cancer HospitalZhengzhou, ChinaContact: Jian ZhouNot yet recruiting
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaContact: Weijie CaoNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- WeiShi
- Trial code
- NCT07569653
- Record updated
- 1 June 2026
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: 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.
Exclusion: 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.