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

Condition(s) studied

Investigational drug(s) / intervention(s)

CMV-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.

Standard 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.

Study 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

Primary outcome measure(s)

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

Trial sites (12)

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