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NCT04507477

Ex-vivo Delivery of Rituximab to Prevent PTLD in EBV Mismatch Lung Transplant Recipients: A Pilot Trial

Status unknown Phase 1, PHASE2 Last updated 2 August 2022
What this trial tests

Phase 1, PHASE2 trial testing Rituximab in Epstein-Barr Virus Infections in 10 participants. Status unknown.

Timeline
7 July 2020
Primary endpoint
7 December 2022
7 February 2023

Quick facts

Lead sponsorUniversity Health Network, Toronto
PhasePhase 1, PHASE2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment10
Start date7 July 2020
Primary completion7 December 2022
Estimated completion7 February 2023
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University Health Network, Toronto

Who can join

18 and older, any sex, with Epstein-Barr Virus Infections or Post-transplant Lymphoproliferative Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Post-transplant lymphoproliferative disorders (PTLD) can present as a type of malignancy that limits patient and graft survival after solid organ transplantation. Many early PTLDs are driven by the Epstein-Barr Virus (EBV). Once acquired, EBV virus establishes latency in B-cells and can reactivate under immunosuppression. The highest risk transplant type to develop PTLD are lung transplants who have newly acquired EBV from their donors (D+/R-). There are no good modalities to prevent PTLD from developing after transplant. Rituximab is a monoclonal antibody that depletes B-cells thereby also reducing the burden of EBV. However, rituximab can have toxicities when given intravenously including infusion reactions and increased risk of reactions. Furthermore, more than one dose is usually required. The Toronto Transplant program has developed a technology called ex vivo lung perfusion that repairs lungs outside of the body. Preliminary work has shown that rituximab given through the EVLP circuit can coat B-cells. We have also shown that there is no toxicity to the lung by giving rituximab. The current highly novel study proposes to treat donor lungs ex-vivo with rituximab in order to decrease the amount of B-cells and EBV in the graft. These lungs will then be transplanted into EBV negative patients with the hope that transmission of EBV would be reduced or prevented. Ten patients will be included in the current trial. Outcomes include safety, EBV viral load, and B-cell measurements in biopsies.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. How I treat posttransplant lymphoproliferative disorder.
    Amengual JE, Pro B. · · 2023 · cited 27× · PMID 37540819 · DOI 10.1182/blood.2023020075
  2. Feasibility and Safety of Ex Vivo Delivery of Rituximab to Lung Allografts in Transplant Recipients at High Risk for Epstein-Barr Virus-associated Posttransplant Lymphoproliferative Disorder.
    Ferreira VH, Ribeiro RVP, Mavandadnejad F, Ierullo M, et al · · 2025 · PMID 40166628 · DOI 10.1097/txd.0000000000001784

Verify or expand the search:

Other trials of Rituximab

Trials testing the same drug.

Other recruiting trials for Epstein-Barr Virus Infections

Currently open trials in the same condition.

Other University Health Network, Toronto trials

Trials by the same sponsor.

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Data sources for this page

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