Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

>= 2 years and < 18 years at the time of enrollment

Weight must be >= 6 kg at the time of enrollment

Planned allogeneic HCT (bone marrow, peripheral blood stem cell, or cord blood transplant)

Patient must be CMV sero-positive (i.e., recipient CMV immunoglobulin G positive)

Disqualifiers

Expected inability to tolerate oral formulation of letermovir

Hypersensitivity to letermovir or any component of the formulation

History of CMV end organ disease within 6 months (180 days) prior to enrollment

Note: CMV end organ disease based on proposed definitions by Ljungman et al. and inclusive of proven, probable or possible disease

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Letermovir

Treatment groups

105 Participants
are divided into 2 treatment groups

Locations

29
Alabama
Children's Hospital of Alabama35233, Birmingham United States
California
UCSF Benioff Children's Hospital Oakland94609, Oakland United States
UCSF Medical Center-Mission Bay94158, San Francisco United States
Colorado
Children's Hospital Colorado80045, Aurora United States

Sponsors and collaborators

Children's Oncology Group

Lead sponsor

Source ClinicalTrials.gov