The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients
Start Date
11/20/2024
Completion Date
12/31/2027
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Hematopoietic Cell Transplant
Letermovir
Conditions
Locations
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States