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

NCT ID: NCT05969743

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-07-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Letermovir

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients
• After allogeneic transplantation
• Seropositive for CMV
• Who already received letermovir prophylaxis until day 100 without CMV reactivation
• Beyond day 100 after transplantation at enrollment
• With acute or chronic GVHD
• Daily prednisone dose ≥ 0.5 mg/kg (or equivalent dose of another glucocorticoid) at enrollment.
• Negative polymerase chain reaction (PCR) for CMV at enrollment
• Provided informed consent

Exclusion Criteria

• Seronegative for CMV
• Positive PCR for CMV at enrollment
• Patient has previously had CMV reactivation under letermovir.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moshe Yeshurun, MD

Role: PRINCIPAL_INVESTIGATOR

Institution of Hematology, Rabin Medical Center

Central Contacts

Moshe Yeshurun, MD

Role: CONTACT

moshe.yeshurun@gmail.com

0526015543

Other Identifiers

0827-22-RMC

Identifier Type: -

Identifier Source: org_study_id