T-cell–guided letermovir stopping after allogeneic stem cell transplant
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.
This tests whether using a CMV-specific T-cell blood test to decide when adult CMV-positive patients can stop letermovir after allogeneic stem cell transplant keeps them protected while avoiding unnecessary drug exposure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT07569653 on ClinicalTrials.gov |
What this trial studies
This randomized Phase 4 trial compares a personalized approach using QuantiFERON-CMV T-cell monitoring to guide letermovir discontinuation versus standard-duration letermovir prophylaxis after allogeneic hematopoietic stem cell transplant. Participants who are CMV-seropositive (R+) are randomly assigned to have letermovir stopped when CMV-specific T-cell recovery is documented or to receive routine prophylaxis for the standard period. The study will track CMV infection/disease rates and safety outcomes to determine whether the T-cell–guided strategy maintains protection while shortening prophylaxis for some patients. The intervention is implemented at a single center in Wuhan with regular blood testing and clinical follow-up.
Who should consider this trial
Good fit: Adults (≥18) who received an allogeneic HSCT, are CMV-seropositive (R+), expect to survive >6 months, and can consent and attend follow-up visits are eligible.
Not a fit: Patients with active CMV infection/disease at screening, known letermovir allergy, severe liver or kidney failure, pregnancy or breastfeeding, or those unable to mount CMV-specific T-cell responses are unlikely to benefit from the guided discontinuation approach.
Why it matters
Potential benefit: If successful, this approach could let some patients stop letermovir earlier, reducing drug exposure, side effects, and cost while keeping CMV risk controlled.
How similar studies have performed: Observational studies and smaller trials have shown that CMV-specific T-cell assays can predict protection and inform prophylaxis decisions, but large randomized evidence for letermovir duration guided by T-cell monitoring remains limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhan, Hubei
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: wei MD, PhD
- Email: shiwei076@hust.edu.cn
- Phone: +86 027-85726003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.