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	CISSS DES LAURENTIDES HOPITAL DE SAINT-JEROME 290 Rue de Montigny, Saint-Jérôme, QC, J7Z 5T3
Ville	Saint-Jérôme
Investigateur(trice) principal(e)	Dr Ghislain Cournoyer
Coordonnateur(trice)	Yanick Sardin Laframboise 450-431-1020 poste 23429
Statut	Fermé
Date d'activation	07-05-2024
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