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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
120
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.
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.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
NOT_YET_RECRUITINGJingzhou First People's Hospital
Jingzhou, Hubei, China
NOT_YET_RECRUITINGJingzhou Central Hospital
Jingzhou, Hubei, China
NOT_YET_RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGTongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
NOT_YET_RECRUITINGZhongnan Hospital of Wuhan University
Wuhan, Hubei, China
NOT_YET_RECRUITINGThe Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
NOT_YET_RECRUITING...and 2 more locations
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).
Time frame: Through 200 days post-transplantation
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.
Time frame: Through 200 days post-transplantation
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