Groupe d'Etude en Oncologie du Quebec

Titre	A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma
Protocole ID	EPCORE FL-1
ClinicalTrials.gov ID	NCT05409066
Type(s) de cancer	Lymphome non-hodgkinien (LNH)
Phase	Phase III
Stade	Lymphome folliculaire/zone marginale
Type étude	Clinique
Médicament	Epcoritamab en association avec rituximab et lénalidomide (R2) comparé à R2
Institution	CHU DE QUEBEC – UNIVERSITE LAVAL HOPITAL DE L'ENFANT-JESUS 1401 18e Rue, Québec, QC, G1J 1Z4
Ville	Québec
Investigateur(trice) principal(e)	Dr Jean-François Larouche
Coordonnateur(trice)	Philippe Nadeau 418-649-0252 poste 63115
Statut	Actif en recrutement
Date d'activation	13-11-2023
Critètes d'éligibilité	Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2. Participant has: Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND >= 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI. Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a FL] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ on a representative tumor biopsy based on the pathology report. Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.) Eligible to receive R2 per investigator determination
Critètes d'exclusion	Documented refractoriness to lenalidomide. Have lenalidomide exposure within 12 months prior to randomization.

Groupe d'étude en oncologie du Québec