NCT05969743

Letermovir Prophylaxis for Cytomegalovirus (CMV) in Patients With Graft-versus-host Disease

Letermovir Prophylaxis for CMV in Patients With Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation: a Proof of Concept Multicenter Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Explore the tolerability and efficacy of letermovir in the prevention of CMV reactivation in patients with acute and chronic graft-versus-host disease (GVHD) beyond day 100.

Detailed description

42 patients meeting the inclusion criteria will receive letermovir 480 mg per day. Patients receiving concomitant cyclosporine will receive 240 mg of letermovir. Letermovir will be given during 14 weeks or until prednisone dose is reduced below 0.2 mg / kg / day, whichever comes earlier. All the patients will continue herpesvirus prophylaxis with acyclovir or valacyclovir. Patients will be evaluated biweekly until letermovir discontinuation. A PCR CMV test will be performed biweekly. Patients in whom clinically significant CMV infection (defined as CMV disease or CMV viremia leading to preemptive treatment) develop, will discontinue the trial regimen and begin anti-CMV therapy according to local practice. The threshold for preemptive treatment for CMV viremia will be \>1000 copies/ ml.

Conditions

• Graft-versus-host-disease
• CMV

Interventions

Type	Name	Description
DRUG	Letermovir	Patients meeting the inclusion criteria will receive letermovir 480 mg per day. Patients receiving concomitant cyclosporine will receive 240 mg of letermovir. Letermovir will be given during 14 weeks or until prednisone dose is reduced below 0.2 mg / kg / day, whichever comes earlier.

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-04-30
• Completion: 2025-07-31
• First posted: 2023-08-01
• Last updated: 2023-08-01