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

WeiShi

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Standard Letermovir Prophylaxis; Drug: CMV-Specific T-cell Guided Letermovir Discontinuation

Study type: Interventional

Funder types: Other

Identifiers

NCT07569653

[2025]num(0974)

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT).
2. CMV serostatus of the recipient is positive (R+).
3. Aged 18 years or older.
4. Expected survival > 6 months.
5. 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Experimental (T-cell Guided Group)

Experimental group

Treatment:

Drug: CMV-Specific T-cell Guided Letermovir Discontinuation

Active Comparator (Standard Prophylaxis Group)

Active Comparator group

Treatment:

Drug: Standard Letermovir Prophylaxis