Titre A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
Protocole ID MAHOGANY
ClinicalTrials.gov ID NCT05100862
Type(s) de cancer Lymphome non-hodgkinien (LNH)
Phase Phase III
Stade Récidivant/réfractaire (2ième ligne de traitement et plus)
Type étude Clinique
Médicament Zanubrutinib + anticorps Anti-CD20 versus lénalidomide + rituximab
Institution CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
   HOPITAL FLEURIMONT
      3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
Ville Sherbrooke
Investigateur(trice) principal(e) Dre Dominique Toupin
Coordonnateur(trice) Michelle Roy
 819-346-1110 poste 12848
Statut Actif en recrutement
Date d'activation 06-08-2024
Critètes d'éligibilité Key Inclusion Criteria:
  • Histologically confirmed grade 1-3a FL or MZL
  • Previously treated with ≥ 1 line of systemic therapy including anti-CD20 agent. Must have a documented failure to achieve at least partial response during the most recent systemic therapy or documented progressive disease after the most recent systemic therapy
  • Need for systemic therapy for FL or MZL
  • Measurable disease by computed tomography or magnetic resonance imaging
  • Adequate bone marrow, liver and renal function
Critètes d'exclusion Key Exclusion Criteria:
  • Transformation to aggressive lymphoma
  • Requiring ongoing need for corticosteroid treatment
  • Clinically significant cardiovascular disease
  • Prior malignancy within the past 2 years
  • Active fungal, bacterial, and/or viral infection that requires systemic therapy
  • Prior treatment with lenalidomide or drug from same class, if without response (partial or complete) or short remission duration (< 24 months)