Preventing CMV Infections in High-Risk Adults After Stem Cell Transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the efficacy and safety of extending letermovir prophylaxis to prevent cytomegalovirus (CMV) reactivation in high-risk adults undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Following allo-HSCT, patients are immunocompromised and at increased risk for CMV infections, which can lead to serious complications. The study aims to determine if extending letermovir treatment beyond the standard 100 days can further reduce the incidence of CMV infections in this vulnerable population. Participants will be monitored for CMV reactivation and related outcomes during the extended prophylaxis period.

Why it matters

Who can join: the full rules

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).

Where it's running

• Hematology Department, The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Xiaojin Wu, Prof. — The First Affiliated Hospital of Soochow University
• Study coordinator: Xiaojin Wu, Prof.
• Email: wuxiaojin@suda.edu.cn
• Phone: 13057493105

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Preventing CMV with CMVIG after conversion to belatacept in kidney transplant recipients

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.