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NCT Number: NCT07569653

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

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.

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Key information

Conditions

Cytomegalovirus Infections Cytomegalovirus Disease DNA Virus Infections Graft vs Host Disease Hematopoietic Stem Cell Transplantation Herpesviridae Infections Immune System Diseases Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chinese PLA General Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of Clinically Significant CMV Infection (CS-CMVi)

    Time frame: Through 200 days post-transplantation

    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).

Secondary outcomes

  1. Duration of Letermovir Prophylaxis

    Time frame: Through 200 days post-transplantation

    The total number of days each participant received Letermovir prophylaxis from the start of treatment (between Day 0 and Day 28 post-HSCT) until the end of the intervention (up to 200 days). This measure will compare the median duration of medication between the experimental arm (T-cell guided) and the control arm (standard 200-day prophylaxis) to evaluate the reduction in drug exposure.

Study contacts

Contact information is provided by the study sponsor or research team.

wei MD, PhD

CONTACT

[email protected]

+86 027-85726003

Sponsors and collaborators

Lead sponsor

WeiShi

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 6, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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