NCT07569653 Letermovir Prophylaxis Duration Guided by CMV-Specific T-cell Monitoring After Allo-HSCT.
| NCT ID | NCT07569653 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | WeiShi |
| Condition | Cytomegalovirus Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-10-30 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2025-10-30 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07569653 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cytomegalovirus Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07569653 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07569653 currently recruiting?
Yes, NCT07569653 is actively recruiting participants. Contact the research team at shiwei076@hust.edu.cn for enrollment information.
Where is the NCT07569653 trial being conducted?
This trial is being conducted at Beijing, China, Shijiazhuang, China, Zhengzhou, China, Zhengzhou, China and 8 additional locations.
Who is sponsoring the NCT07569653 clinical trial?
NCT07569653 is sponsored by WeiShi. The trial plans to enroll 120 participants.