Letermovir Prophylaxis Duration Guided by CMV-Specific T-cell Monitoring After Allo-HSCT.

Recruiting now · Phase 4

Conditions studied: Cytomegalovirus Infections, Cytomegalovirus Disease, Hematopoietic Stem Cell Transplantation, Graft vs Host Disease

In brief

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.

Key facts

Study ID

NCT07569653

Run by

WeiShi

People needed

120

Starts

2025-10-30

Expected to finish

2027-12-01

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 1.Active CMV infection or CMV disease at the time of screening.
• Known hypersensitivity to Letermovir or its excipients.
• Severe hepatic or renal impairment.
• Pregnant or breastfeeding women.

Where it is running

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China
• Henan Cancer Hospital — Zhengzhou, Henan, China
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
• Jingzhou First People's Hospital — Jingzhou, Hubei, China
• Jingzhou Central Hospital — Jingzhou, Hubei, China
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China
• The Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
• Chinese PLA General Hospital — Beijing, Beijing Municipality, China
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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