Letermovir Prophylaxis Duration Guided by CMV-Specific T-cell Monitoring After Allo-HSCT.
A legfontosabb adatok
- Fázis
- 4. fázis
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Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- WeiShi
- Azonosító
- NCT07569653
- A regiszteradat frissítve
- 2026. június 1.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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.