Titre Phase Ib Study of Tisagenlecleucel in Combination With Pembrolizumab in Relapsed/Refractory (r/r) Diffuse Large B-cell Lymphoma (DLBCL) Patients.
Protocole ID CCTL019J2101 (PORTIA)
ClinicalTrials.gov ID NCT03630159
Type(s) de cancer Lymphome non-hodgkinien (LNH)
Phase Phase I
Stade Récidive
Type étude Traitement
Médicament Tisagenlecleucel avec Pembrolizumab
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) Dre Isabelle Fleury
Coordonnateur(trice) Olivier Cormier
514-252-3400 poste 5966
Statut Actif en recrutement
Critètes d'éligibilité
  • 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.
Critètes d'exclusion
  • 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.