NCT06639854

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cytomegalovirus Cell Mediated Immunity
• Hematopoietic Cell Transplant

Interventions

Type	Name	Description
PROCEDURE	Hematopoietic Cell Transplant	Participants choices may include to receive standard post-transplant virus prevention with letermovir or other standard drugs without being part of this study. Participants may choose to receive other investigational therapy, if available. These alternative treatments have risks and benefits that may be the same or different than those in this research study.
DRUG	Letermovir	Given by PO

Timeline

• Start date: 2024-11-20
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-10-15
• Last updated: 2025-11-06

Locations

1 site across 1 country: United States