Letermovir (LMV) Prophylaxis in CMV-seronegative Allogeneic Stem Cell Transplant Recipients With CMV Seropositive Donors: an Exploratory Study From Spanish GETH/TC Centers

Launched by GRUPO ESPANOL DE TRASPLANTES HEMATOPOYETICOS Y TERAPIA CELULAR · Jan 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Letermovir (LMV) to help prevent a virus known as cytomegalovirus (CMV) in patients who have received a stem cell transplant. Specifically, the trial focuses on patients who have tested negative for CMV themselves but are receiving stem cells from a donor who is positive for the virus. The goal is to see how effective LMV is in preventing CMV infections in these patients compared to a historical group of patients who did not receive this medication.

To be eligible for this study, participants must be at least 18 years old and be undergoing their first stem cell transplant. They should also have no current CMV infection and meet other specific health criteria. If you join the study, you will receive LMV as part of your treatment, and the research team will monitor your health throughout the trial. It’s important to know that this trial is not yet recruiting participants, but it aims to provide valuable insights into improving care for stem cell transplant recipients at risk for CMV.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years
• • First allogenic HCT
• • Pre-HCT patient CMV negative IgG serology with CMV IgG positive donor serostatus
• • Able to provide written consent and complete the informed consent
• • Absence of CMV DNAemia requiring antiviral therapy within 5 days before initiation of LMV. Low levels CMVDNAemia before the inception of letermovir are allowed
• • Exclusion Criteria
• • Active pre-emptive therapy for csCMV-I.
• • Patients who have received LMV prophylaxis prior to enrollment
• • Patients enrolled in a CMV pre-emptive therapy clinical trial
• • Glomerular filtration rate (GFR) \</=30 mL/min/1.73m\^2 (equivalent to creatinine clearance \</=10 mL/min)
• • Severe hepatic function grade 3-4 CTAE at the time of study entry.
• • Suspected or known hypersensitivity to active or inactive ingredients of LMV formulations
• • History of allergic reactions attributed to compounds of similar chemical or biologic composition to letermovir.
• • Pregnancy or breastfeeding
• • Plans to conceive or father children within the projected duration of the trial
• • History of current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or would place the subject at undue risk as judged by the investigator, such that it is not in the best interest of the subject to participate in this study