Titre A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Protocole ID BGB-11417-301
ClinicalTrials.gov ID NCT06073821
Type(s) de cancer Leucémie lymphoïde chronique (LLC)
Phase Phase III
Type étude Clinique
Médicament Sonrotoclax + zanubrutinib comparé à vénétoclax + obinutuzumab
Institution CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL  
Ville Montréal
Investigateur(trice) principal(e) Dr Stéphane Doucet
Coordonnateur(trice) Chantal Gosselin
 514-890-8000 poste 24892
Statut Actif en recrutement
Date d'activation 04-10-2024
Critètes d'éligibilité
  • Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment
  • Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
  • Measurable disease by Computer Tomography/Magnetic Resonance Imaging
  • Adequate liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin < 3.0 x ULN
  • Adequate renal function as defined as creatinine clearance ≥ 50 milliliters per minute
Critètes d'exclusion
  • Previous systemic treatment for CLL
  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
  • Known central nervous system involvement
  • History of confirmed progressive multifocal leukoencephalopathy (PML)
  • Uncontrolled hypertension