Lymphome non-hodgkinien (LNH)

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  • Lymphome non-hodgkinien (LNH)
  • OLYMPIA-1

TITRE (EN) 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
CLINICAL TRIAL.gov ID NCT06091254
TYPE(S) DE CANCER Lymphome non-hodgkinien (LNH)
PHASE Phase III
TYPE D'ÉTUDE Clinique
INSTITUTION CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
3001 12e Avenue Nord
(819) 346-1110
VILLE Sherbrooke
INVESTIGATEUR(RICE) PRINCIPAL(E) Stéphanie Corriveau-Désilets
COORDONATEUR(RICE) Mégane Lebel
megane.lebel.ciussse-chus@ssss.gouv.qc.ca
819-346-1110 poste 14138
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)

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
CRITÈRES D'EXCLUSION (EN)

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