RecruitingPhase 4NCT07569653

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

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.


Sponsor

WeiShi

Enrollment

120 participants

Start Date

Oct 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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.

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Interventions

DRUGCMV-Specific T-cell Guided Letermovir Discontinuation

Patients receive Letermovir prophylaxis (480 mg/day orally or IV) according to the standard protocol until approximately 100 days post-transplantation, regardless of T-cell recovery status.

DRUGStandard Letermovir Prophylaxis

Patients receive Letermovir prophylaxis (480 mg/day orally or IV) according to the standard protocol until approximately 100 days post-transplantation, regardless of T-cell recovery status.


Locations(12)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

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

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, 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

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07569653


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