RecruitingHematopoietic and Lymphoid Cell NeoplasmMalignant Solid Neoplasm

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

Eligible age

2–18 yrs

Accepts

All genders

Locations

20 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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.

Sponsor: Children's Oncology Group

You may qualify if…

✓ \>= 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)
✓ Note: If a patient has hypogammaglobulinemia but has previously been documented as CMV sero-positive, that is acceptable for study inclusion. For all patients already confirmed to be CMV IgG seropositive, repeat testing is not required within 7 days prior to enrollment. However, the laboratory data determining eligibility must be available in the patient's medical/research record for verification
✓ Patient is eligible for entry only if it is feasible for plasma CMV PCR testing to be sent and resulted within the protocol mandated time period
✓ Reminder: To limit the likelihood of positive plasma CMV PCR post-enrollment and prior to start of study treatment period, it is recommended that patient enrollment proceed after patients start their transplant preparative regimen
✓ Patient must have a performance status corresponding to Lansky/Karnofsky scores \> 50

You may not qualify if…

✕ 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
✕ Receipt of prior allogeneic HCT within one year of study enrollment
✕ Planned prophylactic administration of other anti-CMV medications or cellular products during the study, including:
✕ High dose acyclovir (defined as doses \>= 1500 mg/m\^2 IV or \>= 3200 mg oral (patients \>= 40 kg) or \>= 2400 mg/m\^2 (patients \< 40 kg) per day)
✕ High dose valacyclovir (defined as doses \>= 3000 mg/day in patients \> 20 kg)