TITRE Étude de phase Ib sur l’utilisation du tisagenlecleucel en association avec le pembrolizumab dans le traitement du lymphome diffus à grandes cellules B (LDGCB) récidivant ou réfractaire (r/r)
PROTOCOLE ID CCTL019J2101 (PORTIA)
CLINICAL TRIAL.gov ID NCT03630159
TYPE(S) DE CANCER Lymphome non-hodgkinien (LNH)
PHASE Phase I
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) Isabelle Fleury
COORDONATEUR(RICE) Olivier Cormier
olivier.cormier.cemtl@ssss.gouv.qc.ca
514-252-3400 poste 5966
STATUT  Fermé
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • Confirmed DLBCL per local histopathology assessment.
  • Relapsed or refractory disease after having recieved 2 or more lines of systemic therapy, including anti-CD20 and anthracycline based chemotherapy, and either having progressed after (or relapsed after) ASCT, or being not candidates for or not consenting to ASCT.
  • Measurable disease at time of enrollment
  • ECOG performance status that is either 0 or 1 at screening.
CRITÈRES D'EXCLUSION (EN)
  • Patients with Richter's transformation, and Burkitt lymphoma, and primary DLBCL of CNS.
  • Prior treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy.
  • Patients with active CNS involvement are excluded, except if the CNS involvement has been effectively treated and provided that local treatment was >4 weeks before enrollment.
  • Prior allogeneic HSCT.
  • Unstable angina and/or myocardial infarction and/or coronary artery bypass graft (CABG), or stroke within 6 months prior to screening, and/or impaired cardiac function or clinically significant cardiac disease
  • Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, other immune checkpoint inhibitors.
  • History of interstitial lung disease or (non-infectious) pneumonitis that required oral or intravenous steroids (other than COPD exacerbation) or current pneumonitis.

Other protocol-defined inclusion/exclusion criteria may apply.