Groupe d'Etude en Oncologie du Quebec

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	CHU DE QUEBEC – UNIVERSITE LAVAL HOPITAL DE L'ENFANT-JESUS 1401 18e Rue, Québec, QC, G1J 1Z4
Ville	Québec
Investigateur(trice) principal(e)	Dr Jean-François Larouche
Coordonnateur(trice)	Philippe Nadeau 418-649-0252 poste 63115
Statut	Interruption temporaire
Date d'activation	19-02-2024
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

Groupe d'étude en oncologie du Québec