| 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.
|
Groupe d'étude en oncologie du Québec