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.
Solid organ transplant recipients with persistent Epstein-Barr virus (EBV) DNAemia are at increased risk for post-transplant lymphoproliferative disorder (PTLD), and optimal preemptive management remains undefined. This Phase 1 study evaluates the efficacy and safety of rituximab in this population, with primary endpoints of EBV DNAemia clearance at 6 months. All participants will receive a single dose of intravenous rituximab (375 mg/m\^2).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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.
Clearance of EBV DNAemia
Evaluate the efficacy of rituximab for clearance of EBV DNAemia in solid organ transplant recipients as measured by complete response (CR) rate at 6 months post-rituximab. CR is defined as resolution of viremia below the limit of detection.
Time frame: 6 months post-treatment
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