The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients
- Conditions
- Cytomegalovirus Cell Mediated ImmunityHematopoietic Cell Transplant
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 105
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States