The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients
M.D. Anderson Cancer Center
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.
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 mort…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria 1. Allogeneic HCT recipients with positive CMV serostatus 2. On letermovir prophylaxis at day 90 post transplant (+/- 7 days) 3. At high risk for CMV reactivation after day +100: 1. Prior or active graft versus host disease requiring systemic steroids 2. 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) 3. Received T cell depletion or anti thymoglobulin during conditioning 4. CMV reacti…
Interventions
- ProcedureHematopoietic 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.
- DrugLetermovir
Given by PO
Location
- The University of Texas MD Anderson Cancer CenterHouston, Texas