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Rituximab for PTLD Prevention in Solid Organ Transplant Recipients With EBV DNAemia
Sponsor: Jennifer Amengual
Summary
People who have received a solid organ transplant can develop ongoing Epstein-Barr virus (EBV) infection in the blood, which increases the risk of a serious cancer called post-transplant lymphoproliferative disorder (PTLD). This study will test whether rituximab, a drug approved by the U.S. Food and Drug Administration (FDA) for several immune-related conditions, can safely clear EBV from the blood and help prevent PTLD when lowering immune-suppressing medications is not possible or effective. The study includes an initial smaller group focused on determining whether EBV can be cleared, followed by a larger group designed to determine whether treatment lowers the risk of developing PTLD. Researchers will also monitor side effects, transplant organ health, and immune system changes to better understand treatment safety and benefit.
Official title: A Phase 1 Trial of Rituximab in Addition to Standard of Care for the Prevention of Post-Transplant Lymphoproliferative Disorder in Solid Organ Transplant Recipients With EBV DNAemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2026-12
Completion Date
2028-07
Last Updated
2026-09-17
Healthy Volunteers
No
Interventions
Rituximab
Rituximab is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Participants will receive a single dose of 375 mg/m\^2 by intravenous administration.