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Letermovir for Cytomegalovirus Prophylaxis in Patients With Hematological Malignancies Treated With Alemtuzumab
This phase II trial studies how well letermovir works for the prevention of cytomegalovirus reactivation in patients with hematological malignancies treated with alemtuzumab. Patients receiving treatment with alemtuzumab may experience cytomegalovirus reactivation. Letermovir may block cytomegalovirus replication and prevent infection.
PRIMARY OBJECTIVE: I. To estimate the rate of cytomegalovirus (CMV) reactivation in patients treated with letermovir at 3 months after completion of alemtuzumab therapy. SECONDARY OBJECTIVES: I. To evaluate the tolerability of letermovir in combination with alemtuzumab. II. To evaluate the efficacy of letermovir for the prevention of clinically significant CMV disease. III. To estimate the progression free survival of patients in the study population. IV. To estimate the overall survival of patients in the study population. EXPLORATORY OBJECTIVE: I. To evaluate mechanisms of antiviral resistance in letermovir prophylaxis failures. OUTLINE: Beginning within 7 days of the first administration of standard alemtuzumab, patients receive letermovir orally (PO) (or intravenously \[IV\] over 1 hour if patient is unable to take PO for an extended period of time) daily on days 1-28. Cycles repeat every 28 days for up to 3 months after the last dose of alemtuzumab in the absence of unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Start Date
September 15, 2020
Primary Completion Date
November 24, 2023
Completion Date
April 9, 2024
Last Updated
February 28, 2025
6
ACTUAL participants
Letermovir
DRUG
Lead Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
NCT05006716
NCT07277231
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06859424