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A Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients

NCT05711667 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-05-05

No results posted yet for this study

Summary

This phase III single arm trial determines whether taking prophylactic letermovir will reduce the likelihood of infection with cytomegalovirus (CMV) in children and adolescents after stem cell transplant compared to estimated rate of infection without prophylaxis. The treatments used to prepare for HCT reduce the body's natural infection-fighting ability and increase the likelihood of an infection with a virus called cytomegalovirus. "Prophylaxis" means to take a drug to prevent a disease or side effect. Letermovir is an antiviral drug that stops cytomegalovirus from multiplying and may prevent cytomegalovirus infection and make the disease less severe.

Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Malignant Solid Neoplasm

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

DRUG

Letermovir

Given PO or IV

Sponsors & Collaborators

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Caitlin W Elgarten · Children's Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-11
Primary Completion
2029-06-30
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05711667 on ClinicalTrials.gov