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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05969743
Other study ID # 0827-22-RMC
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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