RecruitingPhase 4NCT04989491

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

Multicenter Randomized Two Arms Study Evaluating the Efficacy of Prophylactic Rituximab in Adult EBV Negative Kidney Transplant Recipients on Incidence of EBV Primary Infection and Post-transplant Lymphoproliferative Disorders


Sponsor

University Hospital, Strasbourg, France

Enrollment

120 participants

Start Date

Dec 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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. Schachtner60 reported the cases of 5 EBV negative recipients receiving kidney from EBV positive donors after a treatment with Rituximab. Only 2 patients showed a seroconversion and no patients developed neither a viremia nor a PTLD after 49 months of follow-up. The main objective of the investigators study is to evaluate the efficacy of early infusion of Rituximab in the prevention of EBV primary infection and post-transplant lymphoproliferative disorder (PTLD) occurrence in adult EBV negative kidney transplant recipients transplanted with an EBV positive donor.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a single dose of rituximab (a medication that affects the immune system) can prevent a dangerous virus called Epstein-Barr virus (EBV) from infecting kidney transplant recipients who have never had EBV before but received a kidney from a donor who has. **You may be eligible if...** - You are 18 or older and received a kidney (or kidney-pancreas) transplant - You have never been infected with EBV (confirmed by blood tests) - Your donor had EBV - You are willing to use contraception during the study - You are enrolled in a social security or health insurance scheme **You may NOT be eligible if...** - You have an active hepatitis B infection - You are allergic to rituximab - You have severe immune system problems - You have severe heart failure - You are pregnant or breastfeeding - You are currently in another drug clinical trial - You have a psychiatric condition that would prevent study participation Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRituximab

One single dose of rituximab intravenously (IV)

OTHERcontrol group

No treatment


Locations(1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, France

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NCT04989491


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