Actively Recruiting
A Clinical Study on the Efficacy of Extended Letermovir Prophylaxis to Prevent CMV Reactivation in High-Risk Chinese Adults Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Led by The First Affiliated Hospital of Soochow University · Updated on 2026-01-21
330
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of letermovir to prevent cytomegalovirus (CMV) reactivation in adults undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT), who are at high risk due to their weakened immune systems. This study focuses on high-risk Chinese adults and aims to provide strong evidence supporting extended letermovir prophylaxis, as existing guidelines and treatments for CMV prevention post-allo-HSCT are limited and sometimes unclear in China. The study addresses the need to reduce CMV infections that can occur late after transplantation, which can affect transplant outcomes. Participants receive letermovir starting from day 0 to day 28 after allo-HSCT, with dosing adjusted if combined with cyclosporine. The study compares two groups: one receiving letermovir prophylaxis extended until 24 weeks (about 170 days) post-transplant, and the other group receiving prophylaxis only until 14 weeks (about 100 days) post-transplant. Medication is distributed and adherence is monitored by study nurses during hospitalization, with careful documentation throughout the treatment periods. During the study, participants will be closely monitored for CMV infections, including clinically significant CMV infection within 24 weeks after transplantation, and for other outcomes like resistant CMV infections, graft-versus-host disease (GVHD), adverse events, and mortality. The study includes regular assessments and documentation of medication adherence. The total study participation duration covers at least 24 weeks post-transplant, with ongoing evaluation of the safety and effectiveness of extended letermovir use in this high-risk population.
CONDITIONS
Brief Title
Efficacy of Extended Letermovir Prophylaxis to Prevent CMV Reactivation in High-Risk Chinese Adults Undergoing Allogeneic HSCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have decided to undergo their first allogeneic hematopoietic stem cell transplantation (allo-HSCT)
- Patients aged 18 years or older
- Patients who are CMV seropositive prior to transplantation
- Patients with at least one high-risk factor for CMV reactivation, such as haploidentical, HLA-mismatched, or unrelated donor transplantation; cord blood stem cells; total body irradiation conditioning; or GVHD prophylaxis with alemtuzumab or high-dose anti-thymocyte globulin (ATG)
- Patients able to comply with the study visit schedule, understand and agree to protocol requirements, and have signed informed consent
- Patients with no plans for reproduction from consent date until 90 days after last study dose
You will not qualify if you...
- Patients who previously received any allogeneic hematopoietic stem cell transplantation (allo-HSCT)
- Patients with evidence of CMV viremia before enrollment
- Patients with CMV end-organ disease within 6 months before enrollment
- Patients allergic to letermovir or similar drug components
- Patients with severe liver impairment (Child-Pugh Class C)
- Patients with end-stage kidney disease with creatinine clearance less than 10 mL/min
- Patients requiring mechanical ventilation or with unstable blood flow at enrollment
- Patients who received investigational drug therapy within 28 days before enrollment
- Patients who received or plan to receive cidofovir, CMV immune globulin, or experimental CMV antiviral drugs within 28 days before or during the study
- Patients who participated or plan to participate in CMV vaccine or investigational drug studies
- Patients who are pregnant, breastfeeding, or plan pregnancy within 90 days after last study dose
- Patients positive for HIV antibodies, or with active hepatitis B or C infections within 90 days before randomization
- Patients with active solid cancers except localized basal or squamous cell skin carcinoma or treated lymphoma
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 weeks or up to 24 weeks post-transplant, depending on assignment
Participants receive prophylactic treatment with letermovir starting from day 0 to day 28 post-transplant. Treatment continues either until 14 weeks or 24 weeks post-transplant, depending on group assignment, to prevent CMV reactivation.
Visits occur regularly during treatment to monitor medication adherence and health status
Trial Site Locations
Total: 1 location
1
Hematology Department, The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
X
Xiaojin Wu, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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