Overview
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.
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
Inclusion criteria
- Allogeneic HCT recipients with positive CMV serostatus
- On letermovir prophylaxis at day 90 post transplant (+/- 7 days)
- At high risk for CMV reactivation after day +100:
- Prior or active graft versus host disease requiring systemic steroids
- Mismatch stem cell donor (includes haploidentical, mismatch unrelated donor (MMUD), match related donor with at least one mismatch at one of the three specified HLA gene loci (HLA-A, HLA-B, or HLA-DR) and cord donor recipients)
- Received T cell depletion or anti thymoglobulin during conditioning
- CMV reactivation prior to day 100 post transplant
- On steroids at any dose within 2 weeks of enrollment
Exclusion criteria
- Patients under the age of 18
- Patients are discharged from our institution and unwilling to come back for follow up
- Patients are actively undergoing treatment for CS-CMVi at time of screening. Prior CS-CMVi is not an exclusion from study.
- Patients are allergic or intolerant to letermovir or have history of letermovir resistant CMV infection.
- Not able to procure letermovir for extended prophylaxis beyond day +100.