Condition: Cytomegalovirus Infections · Cytomegalovirus Disease · Hematopoietic Stem Cell Transplantation · Sponsor: WeiShi
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.
This description comes directly from the study's public registry record.
wei MD, PhD · +86 027-85726003 · shiwei076@hust.edu.cn
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| Chinese PLA General Hospital | Beijing, Beijing Municipality, China | Not Yet Recruiting |
| The Second Hospital of Hebei Medical University | Shijiazhuang, Hebei, China | Not Yet Recruiting |
| Henan Cancer Hospital | Zhengzhou, Henan, China | Not Yet Recruiting |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou, Henan, China | Not Yet Recruiting |
| Jingzhou First People's Hospital | Jingzhou, Hubei, China | Not Yet Recruiting |
| Jingzhou Central Hospital | Jingzhou, Hubei, China | Not Yet Recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan, Hubei, China | Recruiting |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan, Hubei, China | Not Yet Recruiting |
| Zhongnan Hospital of Wuhan University | Wuhan, Hubei, China | Not Yet Recruiting |
| The Affiliated Hospital of Inner Mongolia Medical University | Hohhot, Inner Mongolia, China | Not Yet Recruiting |
| The First Affiliated Hospital of Nanchang University | Nanchang, Jiangxi, China | Not Yet Recruiting |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou, Zhejiang, China | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07569653