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

Sponsor

Rabin Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05969743

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Graft-versus-host-disease CMV	Drug: Letermovir	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2025

Anticipated Study Completion Date :

Jul 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Letermovir

Outcome Measures

Primary Outcome Measures

Incidence of CMV infection [14 weeks]
The proportion of patients with clinically significant CMV infection through week 14 after enrollment or until prednisone dose is reduced below 0.2 mg / kg / day, whichever comes earlier.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Rabin Medical Center

Investigators

Principal Investigator: Moshe Yeshurun, MD, Institution of Hematology, Rabin Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rabin Medical Center

ClinicalTrials.gov Identifier:

NCT05969743

Other Study ID Numbers:

0827-22-RMC

First Posted:

Aug 1, 2023

Last Update Posted:

Aug 1, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Graft vs Host Disease

Letermovir

Study Results

No Results Posted as of Aug 1, 2023