Informations générales (source: ClinicalTrials.gov)
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 (REPLY)
Interventional
Phase 4
University Hospital, Strasbourg, France (Voir sur ClinicalTrials)
décembre 2021
décembre 2029
20 août 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Alexandre HERTIG | 05/05/2025 07:12:10 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Les Hôpitaux Universitaires de Strasbourg - 67000 - Strasbourg - France | Sophie Caillard, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Adult patients (age ≥18 years at transplantation)
- Kidney and kidney pancreas simultaneous transplantation
- EBV seronegative patients (IgG anti EBNA, IgG anti VCA and IgM anti VCA negative)
(from 6 months before transplantation to the day of transplantation, included)
- Patient who have given written informed consent
- Negative pregnancy test and use of contraception during all the study
- EBV positive donor
- Patient affiliated to a social security scheme
- Adult patients (age ≥18 years at transplantation)
- Kidney and kidney pancreas simultaneous transplantation
- EBV seronegative patients (IgG anti EBNA, IgG anti VCA and IgM anti VCA negative)
(from 6 months before transplantation to the day of transplantation, included)
- Patient who have given written informed consent
- Negative pregnancy test and use of contraception during all the study
- EBV positive donor
- Patient affiliated to a social security scheme
- Patient with known HBV active infection
- Allergy to Rituximab
- Severe Immune deficiency
- Severe cardiac insufficiency
- Pregnant or lactating women
- Women of child bearing potential unless they are using a birth control method
- Patient under judicial protection or under guardianship
- Patient currently participating in another clinical trial investigating drugs.
Observational studies are not considered as an exclusion criterion
- Any form of substance abuse, psychiatric disorder or condition, which, in the
opinion of the investigator, is incompatible with the participation in the study
- Unlikely to comply with the visits scheduled in the protocol.
Exclusion Criteria:
-