This clinical trial compares interrupted administration of letermovir versus extended duration letermovir in preventing cytomegalovirus (CMV) infections in patients receiving donor (allogeneic [allo]) hematopoietic stem cell transplant (HCT). Following allo-HCT, patients are at risk for multiple viral complications. CMV infection remains a major infectious complication following allo-HCT. Letermovir is in a class of medications called antivirals. It works by slowing the growth of CMV. Using letermovir has, however, resulted in increased rates of late CMV infections after stopping the drug at day 100 or 200 post-transplant. CMV cell mediated immunity (CMV-CMI) is a blood test that has been shown to predict CMV infections after transplant. Previously, it has been noted that patients with high CMV-CMI did not progress to CMV infection, with or without use of letermovir. Using CMV-CMI, doctors may be able to safely interrupt or extend letermovir prevention prior to or beyond day 200 post-transplant.
Additional locations may be listed on ClinicalTrials.gov for NCT06639854.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Fareed Khawaja
Phone: 281-610-0253
PRIMARY OBJECTIVE:
I. To compare the proportion of clinically significant CMV infection (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:
I. 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.
II. To compare the overall use of letermovir in HCT recipients in both arms.
III. To compare CMV CMI in HCT recipients in both arms.
IV. To compare all-cause mortality and non-relapse mortality between the 2 arms at day +200 and day +365.
V. Healthcare expenditures for letermovir use and T-cell immunity panel (TCIP) for both arms from day +100 to day +200.
VI. To correlate Torque Teno virus (TTV) viral load with CS-CMVi in HCT recipients on or off letermovir prophylaxis.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive letermovir daily for up to 200 days post allo-HCT in the absence of unacceptable toxicity. Patients also undergo collection of blood every 2 weeks (Q2W) to assess CMV-CMI. Patients with a positive CMV-CMI stop receiving letermovir, and restart letermovir if patients become CMV-CMI negative. Patients also undergo additional collection of blood throughout the study.
ARM II: Patients receive letermovir daily for up to 200 days post allo-HCT in the absence of unacceptable toxicity. Patients also undergo collection of blood at enrollment and at day 200 post allo-HCT to assess CMV-CMI. Patients also undergo additional collection of blood throughout the study.
After completion of study treatment, patients are followed up at day 365.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorFareed Khawaja
