Status:

UNKNOWN

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

Lead Sponsor:

University Health Network, Toronto

Conditions:

Epstein-Barr Virus Infections

Post-transplant Lymphoproliferative Disorder

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

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 Ep...

Detailed Description

Previous studies have shown that EBV D+/R- lung transplant patients have a high rate of post-transplant lymphoproliferative disease up to 22%. Various methods have been proposed to decrease the risk o...

Eligibility Criteria

Inclusion

  • Age \>=18 years
  • Listed for single or double lung transplantation
  • EBV (EBNA IgG and/or VCA IgG) seronegative (tested within the last 12 months)

Exclusion

  • EBV seropositivity at any time prior to transplant
  • History of Cancer (eg, lymphoma)
  • History of receiving rituximab or allergy to rituximab
  • Underlying immunodeficiency (eg, common variable immune deficiency)
  • Unable or unwilling to comply with study procedures

Key Trial Info

Start Date :

July 7 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 7 2023

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT04507477

Start Date

July 7 2020

End Date

February 7 2023

Last Update

August 2 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University Health Network, Toronto General Hospital, Multi-Organ Transplant

Toronto, Ontario, Canada, M5G2N2