Letermovir Prophylaxis Duration Guided by CMV-Specific T-cell Monitoring After Allo-HSCT.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CMV-Specific T-cell Guided Letermovir Discontinuation, Standard Letermovir Prophylaxis.
- Who it may be relevant to
- Registry conditions: Cytomegalovirus Infections, Cytomegalovirus Disease, Hematopoietic Stem Cell Transplantation, Graft vs Host Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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
- Drug CMV-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. - Drug Standard 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.
Primary outcome measures
- Incidence of Clinically Significant CMV Infection (CS-CMVi) [Time frame: Through 200 days post-transplantation]
Secondary outcome measures (1)
- Duration of Letermovir Prophylaxis [Time frame: Through 200 days post-transplantation]
Eligibility criteria
Inclusion criteria
- 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 12 centers
- Chinese PLA General Hospital — Beijing
- The Second Hospital of Hebei Medical University — Shijiazhuang
- Henan Cancer Hospital — Zhengzhou
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou
- Jingzhou First People's Hospital — Jingzhou
- Jingzhou Central Hospital — Jingzhou
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
- … and 4 more centers
Identifiers
NCT: NCT07569653 · [2025]num(0974)