Children's Oncology Group
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.
PRIMARY OBJECTIVE: I. To evaluate the efficacy of letermovir prophylaxis in the prevention of clinically significant CMV infection through Week 14 (\~100 days) post-transplant in children and adolescents receiving allogeneic hematopoietic cell transplant (allo-HCT). SECONDARY OBJECTIVE: I. To evaluate the efficacy of letermovir prophylaxis as assessed by CMV-free survival through 24 weeks (\~6 months) post-transplant in pediatric patients. EXPLORATORY OBJECTIVES: I. To evaluate the incidence of clinically significant CMV infection through 24 and 52 weeks post-transplant in patients who re…
Inclusion Criteria: * \>= 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 labor…
Undergo collection of blood samples
Given PO or IV