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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental (T-cell Guided Group) | Experimental |
| |
| Active Comparator (Standard Prophylaxis Group) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMV-Specific T-cell Guided Letermovir Discontinuation | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Through 200 days post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wei MD, PhD | Contact | +86 027-85726003 | shiwei076@hust.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100853 | China |
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| Standard Letermovir Prophylaxis | Drug | 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. |
|
| Through 200 days post-transplantation |
| The Second Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | 050000 | China |
|
| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 450008 | China |
|
| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450052 | China |
|
| Jingzhou First People's Hospital | Not yet recruiting | Jingzhou | Hubei | 434000 | China |
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| Jingzhou Central Hospital | Not yet recruiting | Jingzhou | Hubei | 434020 | China |
|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430022 | China |
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| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430030 | China |
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| Zhongnan Hospital of Wuhan University | Not yet recruiting | Wuhan | Hubei | 430071 | China |
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| The Affiliated Hospital of Inner Mongolia Medical University | Not yet recruiting | Hohhot | Inner Mongolia | 010050 | China |
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| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
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| The First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | Wenzhou | Zhejiang | 325000 | China |
|
| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D007154 | Immune System Diseases |
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