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.
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.
1.Active CMV infection or CMV disease at the time of screening.
Parallel
CMV-Specific T-cell Guided Letermovir Discontinuation
DrugPatients 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
DrugPatients 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.
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).
Duration of Letermovir Prophylaxis
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.
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WeiShi
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Sponsor institution
