NCT06211543

Letermovir (LMV) Prophylaxis in CMV-seronegative Allogeneic Stem Cell Transplant Recipients With CMV Seropositive Donors: an Exploratory Study From Spanish GETH/TC Centers

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Grupo Espanol de trasplantes hematopoyeticos y terapia celular · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an observational cohort study. Two cohort will be enrolled: LMV cohort: All patients included in in this study will receive LMV according to standard of care. Historical cohort: an historical cohort will be included to compare the results of both groups (LMV vs historical cohort).

Detailed description

All patients will receive treatment wtith LMV according to standard of care. Eligible patients will be enrolled in the study under the supervision of the investigator or designated sub-investigators. If possible, patients will receive treatment on an outpatient basis except for the hospitalization requirement established in the protocol. Patients will receive oral or intravenous LMV (if available) at a dose of 480 mg/day. For patients receiving concomitant treatment with cyclosporine, the dose of LMV will be 240 mg/day. According to the standard of care, LMV will be administered daily until week 14 post-transplant for up to 8 weeks (\~day 100) starting on day +1. Patients could be discontinued earlier if, disease progression, patient withdrawal, loss to follow-up, end of study, or death. After completion of the treatment period, an end-of-treatment visit will occur within 30 days of receipt of the last dose of study drug. To compare the outcome of the LMV group, a historical cohort will be selected from the national CMV database (GETH-GRUCINI).

Conditions

• CMV

Timeline

• Start date: 2024-03-30
• Primary completion: 2025-09-30
• Completion: 2026-03-30
• First posted: 2024-01-18
• Last updated: 2024-01-18