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A Study of the Drug Letermovir (LTV) as Prevention for Recurrent of Cytomegalovirus (CMV) Infection

NCT04017962 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-08-11

Study results available
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Summary

The purpose of this study is to determine of letermovir (LTC) is effective at preventing Cytomegalovirus (CMV) infection from returning in people who have already had CMV infection after a bone marrow transplant.

Conditions

  • CMV
  • CMV Infection
  • Hematopoietic Cell Transplant

Interventions

DRUG

Letermovir Pill

Patients enrolled on the study will receive oral LTV 480 mg daily (240 mg daily for patients receiving cyclosporine A). The maximum duration of LTV administration will be 14 weeks. Patients receiving oral medication will be administered a pill diary for drug compliance purposes. This will be administered and reconciled in clinic.

OTHER

blood draw

Collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180.

Sponsors & Collaborators

Principal Investigators

  • Genovefa Papanicolaou · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-19
Primary Completion
2024-08-07
Completion
2025-07-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04017962 on ClinicalTrials.gov