Titre |
A Phase I/II Open-label Study of the Safety and Efficacy of Epstein-Barr Virus Specific T-cell Lines for the Treatment of EBV Infection or EBV-related Lymphoproliferative Diseases |
Protocole ID |
EBV-TCL-01 |
ClinicalTrials.gov ID |
NCT02580539 |
Type(s) de cancer |
Lymphome non-hodgkinien (LNH) |
Phase |
Phase I-II |
Type étude |
Traitement |
Institution |
CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX
5415 boul. de l'Assomption, Montréal, QC, H1T2M4
|
Ville |
Montréal |
Investigateur(trice) principal(e) |
Dr Jean-Sébastien Delisle
|
Coordonnateur(trice) |
Stéphanie Thiant
514-252-3400 poste 4681
|
Statut |
Fermé |
Critètes d'éligibilité |
- 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.
|
Critètes d'exclusion |
- 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
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