RITUXIMAB for Epstein-Barr virus infection | Post-transplant lymphoproliferative disorder | Kidney transplant recipient

Inclusion criteria

• {"criterion_text":"- Adult patients (age ≥18 years at transplantation)"}
• {"criterion_text":"- Kidney and kidney pancreas simultaneous transplantation"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Pediatric patients > 2 years and <18 years at transplantation"}
• {"criterion_text":"- Patient who have given written informed consent"}
• {"criterion_text":"- Negative pregnancy test and use of contraception during all the study or during 12 months after the administration of rituximab in case of early discontinuation of study-EBV positive donor"}
• {"criterion_text":"- EBV positif donnor"}

Exclusion criteria

• {"criterion_text":"- Patient with known HBV active infection"}
• {"criterion_text":"- Unlikely to comply with the visits scheduled in the protocol"}
• {"criterion_text":"- Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients"}
• {"criterion_text":"- Active severe infection"}
• {"criterion_text":"- Severe Immune deficiency"}
• {"criterion_text":"- Pregnant or lactating women"}
• {"criterion_text":"- Women of child bearing potential unless they are using an acceptable birth control methods"}
• {"criterion_text":"- Patient under judicial protection or under guardianship"}
• {"criterion_text":"- Patient currently participating in another clinical trial investigating drugs. Observational studies are not considered as an exclusion criterion"}
• {"criterion_text":"- Any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, is incompatible with the participation in the study"}

Primary endpoints

• {"endpoint_text":"- 1 year incidence of a composite criteria: EBV primary infection assessed by a positive blood EBV viral load and/or EBV seroconversion ; and/or occurrence of a post-transplant lymphoproliferative disorder","definition_or_measurement_approach":"Primary endpoint assessed at 1 year: EBV primary infection measured by positive blood EBV viral load (PCR) and/or EBV seroconversion; and/or occurrence of post-transplant lymphoproliferative disorder (PTLD)."}

Secondary endpoints

• {"endpoint_text":"- 1, 2, 3, 4 and 5 years incidence of PTLD after kidney transplantation","definition_or_measurement_approach":"Incidence of PTLD measured at years 1, 2, 3, 4 and 5 post-transplantation."}
• {"endpoint_text":"- Incidence of primary EBV infection evaluated by EBV viremia (PCR blood test) at M1, M2, M3, M6, M12, M24, M36, M48, M60 and EBV seroconversion at M1, M3, M6, M12, M24, M36, M48, M60.","definition_or_measurement_approach":"EBV primary infection assessed by EBV blood PCR at specified months and seroconversion at specified months."}
• {"endpoint_text":"- Delay of occurrence of primary EBV infection","definition_or_measurement_approach":"Time-to-event measurement: delay until primary EBV infection occurrence."}
• {"endpoint_text":"- Delay of occurrence of primary EBV infection","definition_or_measurement_approach":"Duplicate listed endpoint; measures time to primary EBV infection occurrence."}
• {"endpoint_text":"- CD19/CD20 reconstitution at M3, M6, M12, M24","definition_or_measurement_approach":"Assessment of lymphocyte reconstitution (CD19/CD20 counts) at months 3, 6, 12 and 24."}
• {"endpoint_text":"- Number of patients with high EBV viral load who need Rituximab for preemptive therapy in each group","definition_or_measurement_approach":"Count of patients in each group with high EBV viral load requiring preemptive rituximab therapy."}
• {"endpoint_text":"- Graft loss at M1, M2, M3, M6, M12, M24, M36, M48, M60","definition_or_measurement_approach":"Assessment of graft loss at specified months post-transplantation."}
• {"endpoint_text":"- Allograft kidney function evaluated by CKD-EPI formula or by Schwartz formula in pediatric patients at M1, M2, M3, M6, M12, M24, M36, M48, M60Recipient survival at M1, M2, M3, M6, M12, M24, M36, M48, M60","definition_or_measurement_approach":"Kidney function measured by CKD-EPI (adults) or Schwartz (pediatrics) at specified months; recipient survival recorded at same timepoints."}
• {"endpoint_text":"- Incidence of opportunistic infections and malignancies at M1, M2, M3, M6, M12, M24, M36, M48, M60","definition_or_measurement_approach":"Incidence counts of opportunistic infections and malignancies at specified months."}
• {"endpoint_text":"- Incidence of BKV viremia (PCR blood test) M1, M3, M6, M12 and M24","definition_or_measurement_approach":"BK virus viremia assessed by blood PCR at months 1, 3, 6, 12 and 24."}
• {"endpoint_text":"- Delay of BKV viremia","definition_or_measurement_approach":"Time-to-event measurement for onset of BK viremia."}
• {"endpoint_text":"- Incidence of CMV viremia (PCR blood test) at M1, M3, M6, M12 and XML File Identifier: BMpUWXavs2G+LuOr9Bi86K8SCls= Page 12/29 M24","definition_or_measurement_approach":"CMV viremia assessed by blood PCR at months 1, 3, 6, 12 and 24 (text includes formatting artefact)."}
• {"endpoint_text":"- Treatment tolerance: allergic reaction, neutropenia, hospitalization for febrile neutropenia, hypogammaglobulinémia","definition_or_measurement_approach":"Safety/tolerance endpoints recorded as occurrences of allergic reactions, neutropenia, hospitalizations for febrile neutropenia, and hypogammaglobulinemia."}
• {"endpoint_text":"- AE/SAE","definition_or_measurement_approach":"Collection and recording of adverse events (AEs) and serious adverse events (SAEs)."}
• {"endpoint_text":"- All these end points in specific pediatric and adult sub groups","definition_or_measurement_approach":"All listed endpoints will also be analyzed separately in pediatric and adult subgroups."}

France

Latest Decision Or Authorization Date

19-01-2026

Number Of Sites

28

Number Of Participants

100

Primary sponsor

Full Name

Les Hopitaux Universitaires De Strasbourg

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France