Groupe d'Etude en Oncologie du Quebec

Titre	A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma
Protocole ID	OLYMPIA-1
ClinicalTrials.gov ID	NCT06091254
Type(s) de cancer	Lymphome non-hodgkinien (LNH)
Phase	Phase III
Stade	Lymphome folliculaire/zone marginale
Type étude	Clinique
Médicament	Odronextamab versus une thérapie au choix de l'investigateur
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 Christopher Lemieux
Coordonnateur(trice)	Philippe Nadeau 418-649-0252 poste 63115
Statut	Actif en recrutement
Critètes d'éligibilité	Key Inclusion Criteria: Diagnosis of Cluster of Differentiation 20^+ (CD20^+) FL Grade 1-3a, stage II bulky or stage III / IV Need for treatment as described in the protocol Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Adequate bone marrow function and hepatic function
Critètes d'exclusion	Key Exclusion Criteria: Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma Treatment with any systemic anti-lymphoma therapy Infections and allergy/hypersensitivity to study drug or excipient

Groupe d'étude en oncologie du Québec