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

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm

Eligibility Criteria

Sex

ALL

Age

2 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Letermovir — DRUG
  Given PO or IV

Study Details

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.

Key Dates

Start date

Jul 11, 2024

Status verified

Jan 2026

Primary completion

Jun 30, 2029

Completion

Jun 30, 2029

Study Design

Enrollment

105 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: ARM A (Letermovir prophylaxis)
  Patients receive letermovir PO or IV over 60 minutes QD starting on day +1 post-transplant for 14 weeks. Patients undergo collection of blood samples for CMV PCR analysis weekly for 14 weeks, every 2 weeks until week 24, week 32, week 40 and week 52.
• Active Comparator: Arm B (No prophylaxis)
  Patients undergo collection of blood samples for CMV PCR analysis weekly for 14 weeks, every 2 weeks until week 24, week 32, week 40 and week 52. (CLOSED TO ACCURAL 09/29/2025)

Primary Outcome Measure

Clinically significant cytomegalovirus (CMV) infection [ Time Frame: Up to week 14 post-transplant ]

Locations (29)

Find similar trials in Birmingham, AL

Related Studies

• Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Project: Every Child for Younger Patients With Cancer
  Recruiting · Children's Oncology Group · Birmingham, Alabama
• Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas