Study of Extended Letermovir Use to Prevent Cytomegalovirus Reactivation After Allogeneic Stem Cell Transplant in High-Risk Chinese Adults

What this Trial Is About

Researchers are evaluating the use of letermovir to prevent cytomegalovirus CMV reactivation in adults undergoing allogeneic hematopoietic stem cell transplantation allo-HSCT, who are at high risk due to their weakened immune systems. This study focuses on high-risk Chinese adults and aims to provide strong evidence supporting extended letermovir prophylaxis, as existing guidelines and treatments for CMV prevention post-allo-HSCT are limited and sometimes unclear in China. The study addresses the need to reduce CMV infections that can occur late after transplantation, which can affect transplant outcomes. Participants receive letermovir starting from day 0 to day 28 after allo-HSCT, with dosing adjusted if combined with cyclosporine. The study compares two groups one receiving letermovir prophylaxis extended until 24 weeks about 170 days post-transplant, and the other group receiving prophylaxis only until 14 weeks about 100 days post-transplant. Medication is distributed and adherence is monitored by study nurses during hospitalization, with careful documentation throughout the treatment periods. During the study, participants will be closely monitored for CMV infections, including clinically significant CMV infection within 24 weeks after transplantation, and for other outcomes like resistant CMV infections, graft-versus-host disease GVHD, adverse events, and mortality. The study includes regular assessments and documentation of medication adherence. The total study participation duration covers at least 24 weeks post-transplant, with ongoing evaluation of the safety and effectiveness of extended letermovir use in this high-risk population.

Efficacy of Extended Letermovir Prophylaxis to Prevent CMV Reactivation in High-Risk Chinese Adults Undergoing Allogeneic HSCT