Cytomegalovirus Disease, Cytomegalovirus Infections, Graft vs Host Disease, Hematopoietic Stem Cell Transplantation
Conditions
Brief 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.
Interventions
DRUGCMV-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.
DRUGStandard 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.
Sponsors
WeiShi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Letermovir Prophylaxis | Through 200 days post-transplantation | 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. |
Countries
China
Contacts
CONTACTwei MD, PhD
Outcome results
None listed