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

Graft-versus-host-disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05969743
• Other study ID #: 0827-22-RMC
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 1, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: July 2023
• Source: Rabin Medical Center
• Contact: Moshe Yeshurun, MD
• Phone: 0526015543
• Email: moshe.yeshurun[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: July 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• CMV
• Graft vs Host Disease
• Graft-versus-host-disease

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CMV infection	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.	14 weeks