A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
Phase 3 – large-scale trial before approval
Conditions:
Chronic Lymphocytic Leukemia
Sponsor: BeOne Medicines
trial.available_in:
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Overview
The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).
Who can participate
Inclusion Criteria:
* 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 bone marrow and organ function
Exclusion Criteria:
* 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 or clinically significant cardiovascular disease
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Interventions
Sonrotoclax
DRUG
Zanubrutinib
DRUG
Acalabrutinib
DRUG
Venetoclax
DRUG
Locations
24
Australia (7)
Monash Health
Clayton , Victoria
Concord Repatriation General Hospital
Concord , New South Wales
Austin Health
Heidelberg , Victoria
Cabrini Hospital Malvern
Malvern East , Victoria
The Alfred Hospital
Melbourne , Victoria
Genesiscare North Shore
St Leonards , New South Wales
Princess Alexandra Hospital
Woolloongabba , Queensland
Brazil (2)
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo
Canada (4)
Ciusss Nim Hscm
Montreal , Quebec
Jewish General Hospital
Montreal , Quebec
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec
Ciusss de Lestrie Chus
Sherbrooke , Quebec
China (2)
Jiangsu Province Hospital
Nanjing , Jiangsu
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an , Shaanxi
New Zealand (3)
North Shore Hospital
Auckland
Auckland City Hospital
Auckland
Wellington Regional Hospital (Ccdhb)
Wellington
South Korea (5)
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu , Seoul Teugbyeolsi
Severance Hospital Yonsei University Health System
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