Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06812598

Efficacy of Extended Letermovir Prophylaxis to Prevent CMV Reactivation in High-Risk Chinese Adults Undergoing Allogeneic HSCT

Led by The First Affiliated Hospital of Soochow University · Updated on 2026-01-21

330

Participants Needed

1

Research Sites

106 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

After allogeneic hematopoietic stem cell transplantation (allo-HSCT), recipients are immunocompromised and at increased risk of complications, including cytomegalovirus (CMV) infection. International clinical guidelines for the management of CMV infection post-allo-HSCT recommend three main strategies: minimizing infection risk, prevention, and preemptive therapy. However, traditional antiviral agents have not been approved for CMV prophylaxis in allo-HSCT recipients and are associated with significant adverse effects and the development of resistance, leaving the CMV prevention needs of this patient population unmet. Recent studies have demonstrated that letermovir prevents potent and highly specific antiviral activity against CMV, and it has been approved for CMV prophylaxis within the first 100 days post-allo-HSCT. Furthermore, evidence suggests that extending letermovir administration up to 28 weeks further reduces the risk of CMV infection in the later post-transplant period without increasing drug-related mortality. In China, the post-allo-HSCT CMV prevention strategy faces challenges such as limited treatment options, unclear guideline recommendations, non-standardized drug usage in certain medical institutions, and insufficient monitoring. This study aims to provide robust, evidence-based support for the use of letermovir in high-risk CMV reactivation among adult allo-HSCT recipients, thereby broadening clinical treatment choices.

CONDITIONS

Official Title

Efficacy of Extended Letermovir Prophylaxis to Prevent CMV Reactivation in High-Risk Chinese Adults Undergoing Allogeneic HSCT

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients planning to undergo their first allogeneic hematopoietic stem cell transplantation
  • Patients aged 18 years or older
  • Patients who tested positive for CMV antibodies before transplantation
  • Patients with at least one high-risk factor for CMV reactivation, including haploidentical, HLA-mismatched, or unrelated donor transplant; cord blood as stem cell source; conditioning with total body irradiation; or GVHD prevention with alemtuzumab or high-dose anti-thymocyte globulin
  • Patients able to follow study visits, understand and agree to the protocol, and provide informed consent
  • Patients who agree to avoid reproduction from consent until 90 days after last study treatment dose
Not Eligible

You will not qualify if you...

  • Patients who have had a previous allogeneic hematopoietic stem cell transplantation
  • Patients with 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 and creatinine clearance below 10 mL/min
  • Patients requiring mechanical ventilation or with unstable blood circulation at enrollment
  • Patients who took investigational drugs within 28 days before enrollment
  • Patients who took or plan to take cidofovir, CMV immune globulin, or experimental CMV antiviral/biological drugs within 28 days before or during the study
  • Patients who participated or plan to participate in CMV vaccine or investigational drug studies during this trial
  • Pregnant or breastfeeding patients or those planning pregnancy within 90 days after last study dose
  • Patients positive for HIV antibodies before randomization, or positive for hepatitis C antibodies with detectable RNA, or positive for hepatitis B surface antigen within 90 days before randomization
  • Patients with active solid cancers except localized skin basal or squamous cell carcinoma or those currently under treatment for lymphoma or similar conditions

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hematology Department, The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Actively Recruiting

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Research Team

X

Xiaojin Wu, Prof.

CONTACT

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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