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

NCT07569653 | Recruiting Phase 4 DMC

• 1 other identifier: [2025]num(0974)
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cytomegalovirus Infections; Cytomegalovirus Disease; Hematopoietic Stem Cell Transplantation; Graft vs Host Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of Clinically Significant CMV Infection (CS-CMVi)

  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).

  Through 200 days post-transplantation

Secondary Outcomes (1)

• Duration of Letermovir Prophylaxis

  Through 200 days post-transplantation

Study Arms (2)

Experimental (T-cell Guided Group)

EXPERIMENTAL

Drug: CMV-Specific T-cell Guided Letermovir Discontinuation

Active Comparator (Standard Prophylaxis Group)

ACTIVE COMPARATOR

Drug: Standard Letermovir Prophylaxis

Interventions

Standard Letermovir Prophylaxis DRUG

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.

Active Comparator (Standard Prophylaxis Group)

CMV-Specific T-cell Guided Letermovir Discontinuation DRUG

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.

Experimental (T-cell Guided Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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.

Sponsors & Collaborators

• WeiShi: lead

Study Sites (1)

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

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Infections; Graft vs Host Disease

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Immune System Diseases

Central Study Contacts

wei MD, PhD

CONTACT

+86 027-85726003; shiwei076@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 6, 2026
• Study Start: October 30, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)