Status:
UNKNOWN
Letermovir Prophylaxis for Cytomegalovirus (CMV) in Patients With Graft-versus-host Disease
Lead Sponsor:
Rabin Medical Center
Conditions:
Graft-versus-host-disease
CMV
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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 wee...
Eligibility Criteria
Inclusion
- 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
- Seronegative for CMV
- Positive PCR for CMV at enrollment
- Patient has previously had CMV reactivation under letermovir.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05969743
Start Date
October 1 2023
End Date
July 31 2025
Last Update
August 1 2023
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