Title 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
Cancer Type(s) Non-Hodgkin's Lymphoma
Phase Phase III
Stage Indolent Lymphoma
Study Type Clinical
Drug Odronextamab versus une thérapie au choix de l'investigateur
Institution CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
   HOPITAL FLEURIMONT
      3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
City
Principal Investigator Dr. Stéphanie Corriveau-Désilets
Coordinator Mégane Lebel
819-346-1110 poste 14138
Status Recruiting
Activation Date
Eligibility Criteria 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
Exclusion Criteria 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