The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients

Not Applicable

Recruiting

• Conditions: Cytomegalovirus Cell Mediated Immunity; Hematopoietic Cell Transplant
• Interventions: Procedure: Hematopoietic Cell Transplant; Drug: Letermovir

• Registration Number: NCT06639854
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

The goal of this laboratory research study is to learn if interrupting a patient's letermovir dosing based on their immune system response can help HSC transplant patients avoid post-treatment CMV infections better than taking letermovir every day without interruption.

Detailed Description

Primary Objective

•To compare the proportion of CS-CMVi in allo-HCT recipients who had interrupted letermovir prophylaxis based on CMV CMI or extended duration of letermovir prophylaxis up to 200 days post transplantation.

Secondary Objectives

* To compare the proportion of CS-CMVi in HCT recipients who had interrupted letermovir prophylaxis based on CMV CMI or extended duration of letermovir prophylaxis at 365 days post transplantation.

* To compare the overall use of letermovir in HCT recipients in both arms.

* To compare CMV CMI in HCT recipients in both arms.

* To compare all-cause mortality and nonrelapse mortality between the 2 arms at day +200 and day +365.

* Healthcare expenditures for letermovir use and TCIP for both arms from day +100 to day +200.

Study Timeline

• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-10
• Study First Posted: 2024-10-15
• Study Start: 2024-11-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-25
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interrupted letermovir prophylaxis	Hematopoietic Cell Transplant	Participants assigned to the investigational group, you will also receive letermovir at first, but depending on the result of the study blood tests, your dose may be paused as long as your immune system shows an immune response against CMV.
Interrupted letermovir prophylaxis	Letermovir	Participants assigned to the investigational group, you will also receive letermovir at first, but depending on the result of the study blood tests, your dose may be paused as long as your immune system shows an immune response against CMV.
Standard letermovir prophylaxis	Hematopoietic Cell Transplant	Participants assigned to the standard care group, you will receive treatment with letermovir every day to prevent CMV infection.
Standard letermovir prophylaxis	Letermovir	Participants assigned to the standard care group, you will receive treatment with letermovir every day to prevent CMV infection.

Primary Outcome Measures

Name	Time	Method
Safety and Adverse Events (AEs).	Through study completion; an average of 1 year.	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Locations

Locations (1)

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States