TITRE Une étude ouverte de phase I/II sur l'innocuité et l'efficacité des lymphocytes T propres au virus d’Epstein-Barr (VEB) pour le traitement d'une infection au VEB ou de maladies lymphoprolifératives liées au VEB
PROTOCOLE ID EBV-TCL-01
CLINICAL TRIAL.gov ID NCT02580539
TYPE(S) DE CANCER Lymphome non-hodgkinien (LNH)
PHASE Phase I-II
TYPE D'ÉTUDE Traitement
INSTITUTION CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
5415 boul. de l'Assomption
(514) 252-3400
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Jean-Sébastien Delisle
COORDONATEUR(RICE) Stéphanie Thiant
sthiant.hmr@ssss.gouv.qc.ca
514-252-3400 poste 4681
STATUT  Fermé
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • Capacity to provide informed consent
  • Age ≥ 18 years old
  • Confirmed treatment-refractory EBV reactivation or EBV-related lymphoma
  • ECOG of 2 or less

DONOR ELIGIBILITY: An allogeneic donor must be a first-degree relative with at least 3/6 HLA compatibility, have consented to donate peripheral blood mononuclear cells, and fulfill the same criteria for stem cell donation according to the hospital's standard operating procedure.

CRITÈRES D'EXCLUSION (EN)
  • Medical condition requiring a corticosteroid dose greater than Prednisone 0.5mg/kg/day (or equivalent) at the time of the infusion.
  • Patient has received T-cell depleting antibodies or stem cell transplantation in the 28 days prior to proposed date of anti-EBV T-cell line infusion
  • Patient has received a solid organ transplant in the 3 months prior to proposed date of anti-EBV T-cell line infusion.
  • Pregnant or nursing females
  • Life expectancy of less than 3 months due to a condition unrelated to the EBV- related disease.
  • Active uncontrolled GVHD
  • Active uncontrolled SOT rejection episode