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

Launched by RABIN MEDICAL CENTER · Jul 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called letermovir to see if it can help prevent a virus known as cytomegalovirus (CMV) from coming back in patients who have a condition called graft-versus-host disease (GVHD). GVHD can happen after a stem cell or bone marrow transplant when the new cells attack the patient's body. The trial will focus on patients who are more than 100 days post-transplant and have been receiving letermovir to protect them from CMV without any issues so far.

To participate in this trial, patients need to be adults who have had an allogeneic transplant (using donor cells) and have a positive CMV blood test but are currently free of the virus. They should also be experiencing GVHD and taking a daily dose of a steroid called prednisone to help manage their condition. Participants will need to agree to take part in the study and will be monitored for how well they tolerate the medication and whether it successfully prevents CMV from reactivating. This trial is an important step in finding effective treatments for patients dealing with GVHD and CMV.

Gender

ALL

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.