Lymphome non-hodgkinien (LNH)

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TITRE (EN) 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
CLINICAL TRIAL.gov ID NCT05100862
TYPE(S) DE CANCER Lymphome non-hodgkinien (LNH)
PHASE Phase III
TYPE D'ÉTUDE Clinique
INSTITUTION CHUS
3001 12e Avenue Nord
(819) 346-1110
VILLE Sherbrooke
INVESTIGATEUR(RICE) PRINCIPAL(E) Dominique Toupin
COORDONATEUR(RICE) Michelle Roy
michelle.roy.ciussse-chus@ssss.gouv.qc.ca
819-346-1110 poste 12848
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)

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
CRITÈRES D'EXCLUSION (EN)

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)