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.
|