Study of Letermovir Guided by CMV T Cell Immunity to Prevent CMV Infection After Allogeneic Stem Cell Transplant

What this Trial Is About

Researchers are evaluating the use of the CMV T Cell Immunity Panel CMV-TCIP assay to guide how long primary CMV prophylaxis with letermovir should continue in adults who have received an allogeneic stem cell transplant and are CMV-seropositive. This phase 2, prospective cohort clinical trial focuses on patients who have either a CMV-seropositive donor or recipient. The study aims to better tailor CMV prevention strategies after transplant to reduce the risk of clinically significant CMV infection. Participants receive 14 weeks of letermovir prophylaxis at the standard dose, followed by additional prophylaxis directed by the CMV-TCIP assay results. The CMV-TCIP assay is used monthly starting at week 14 until a positive result, then again at weeks 30 and 52. CMV DNA PCR tests are performed at enrollment, weekly through week 30, and then every two weeks until week 52 if there are no complications. This approach helps guide the duration of extended prophylaxis based on immune response and viral monitoring. During the study, participants undergo regular blood tests for CMV DNA levels and immune response assessments with the CMV-TCIP assay. Researchers measure outcomes including the incidence of clinically significant CMV infection, CMV disease, CMV-related death, and overall survival up to one year after transplant. The study involves close monitoring through the first year after transplant to evaluate how well this personalized prophylaxis approach works and to ensure participant safety.

CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT