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RECRUITING

NCT06812598

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

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

330

Start Date

2024-12-16

Completion Date

2026-12-31

Last Updated

2026-01-21

Healthy Volunteers

Conditions

Cytomegalovirus Infections CMV

Interventions

DRUG

Letermovir (0-24w）

Patients will begin receiving prophylactic treatment with domestically produced letermovir from day 0 to day 28 post-allo-HSCT, at a dose of 480 mg, administered orally once daily. If used in combination with cyclosporine, the dose should be reduced to 240 mg once daily. The treatment will continue until 24 weeks post-transplant (approximately 170 days).

DRUG

Letermovir (0-14w）

Inclusion Criteria: 1. The patients have decided to undergo an initial allogeneic hematopoietic stem cell transplantation (allo-HSCT). 2. The patients are ≥18 years old. 3. The patients are CMV seropositive prior to transplantation. 4. The patients have at least one high-risk factor for CMV reactivation, including: (1) Haploidentical transplantation, HLA-mismatched transplantation, or unrelated donor transplantation. (2) The primary source of stem cells is cord blood. (3) A conditioning regimen including total body irradiation (TBI). (4) A GVHD prophylaxis regimen containing alemtuzumab or high-dose anti-thymocyte globulin (ATG). 5\. The patients are able to comply with the study visit schedule, understand and agree to adhere to all protocol requirements, and have voluntarily signed the informed consent form to participate in the study. 6\. The patients have no plans for reproduction from the date of consent until 90 days after the last dose of the study treatment. Exclusion Criteria: 1. Patients who have previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT). 2. Patients with evidence of CMV viremia at any time prior to enrollment. 3. Patients with a history of CMV end-organ disease within 6 months prior to enrollment. 4. Patients with suspected or known allergy to letermovir or any active or inactive components of similar drugs. 5. Patients with severe hepatic impairment (defined as Child-Pugh Class C). 6. Patients with end-stage renal disease with a creatinine clearance \< 10 mL/min. 7. Patients requiring mechanical ventilation or experiencing hemodynamic instability at the time of enrollment. 8. Patients who received any investigational drug therapy within 28 days prior to enrollment. 9. Patients who received or plan to receive any of the following treatments within 28 days prior to enrollment or during the study: cidofovir, CMV immune globulin, or any experimental CMV antiviral drugs/biological therapies. 10. Patients who previously participated or are currently participating in any study involving a CMV vaccine or other CMV investigational drugs, or who plan to participate in such studies during this trial. 11. Patients who are pregnant or breastfeeding at the time of enrollment or planning to become pregnant within 90 days after the last dose of study medication. 12. Patients who test positive for human immunodeficiency virus antibodies (HIV-Ab) at any time prior to randomization, or who test positive for hepatitis C virus antibodies (HCV-Ab) with detectable HCV RNA, or for hepatitis B surface antigen (HBsAg) within 90 days prior to randomization. Laboratory testing for HIV, HBV, or HCV is allowed using locally acceptable methods. 13. Patients with active solid malignancies, except for localized basal cell or squamous cell carcinoma of the skin or a condition currently under treatment (e.g., lymphoma).

Locations (1)

Hematology Department, The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China