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 CISSS DE CHAUDIERE-APPALACHES
   HOTEL-DIEU DE LEVIS
      143 rue Wolfe, Lévis, QC, G6V 3Z1
Ville Beauceville
Investigateur(trice) principal(e) Dre Danièle Marceau
Coordonnateur(trice) Pierre Bédard
 418-835-7121
Statut Actif en recrutement
Date d'activation 26-10-2023
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.