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Study identifier: NCT04989491 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Evaluation of the Efficacy of a Treatment by One Single Dose of Rituximab (375mg/m2 ) in the Prevention of the Epstein Barr Virus (EBV) Primary Infection and Post-transplant Lymphoproliferative Disorder in Adult EBV Seronegative Patients Who Received an EBV Seropositive Kidney Allograft

Condition: Epstein-Barr Virus Infections  ·  Sponsor: University Hospital, Strasbourg, France

PhasePhase 4
Planned participants120
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Epstein Barr virus infects over 90% of human population and persists during lifetime. After infecting B lymphocytes, EBV remains latent in memory B cells. In immunocompromised patients, primary infection could lead to an uncontrolled EBV infected B cells proliferation because of impaired T cell specific cytotoxicity. The latent EBV infection is characterized by expression of restricted latent gene products, which drive cell proliferation and progression to PTLD. As a consequence, EBV seronegativity and EBV mismatch are major risk factors for developing PTLD. The investigators reported in a previous work from the French Registry that the incidence of PTLD was multiplied by ten in adult EBV negative kidney transplant recipients. Moreover, even if the event is relatively rare after transplantation, the prognosis is severe with high morbidity and an overall mortality rate around 50%. Nowadays, few and inconsistent data exist regarding beneficial preventing strategies like antiviral therapy, reduction of immunosuppression or immunoglobulin infusion in this high-risk population of EBV negative recipients. Therefore, an efficient and safe preventive treatment is still lacking to decrease PTLD incidence. Rituximab, has been already proposed in stem cell transplant recipients as a preemptive therapy in patients with a persistent EBV viremia independently of their EBV status. A pilot study was performed in EBV negative kidney transplant recipients but in a very small population. Scha…

This description comes directly from the study's public registry record.

Talk to the study team

Sophie Ohlmann-Caillard  ·  0369550511  ·  sophie.caillard@chru-strasboourg.fr

Always discuss trial participation with your own doctor first.

Locations (1)

Les Hôpitaux Universitaires de StrasbourgStrasbourg, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT04989491