Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)
Phase 3 – large-scale trial before approval
Conditions:
CLL
Sponsor: BeOne Medicines
trial.available_in:
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Overview
The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)
Description
Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms.
In this study, participants with CLL without prior treatment will receive either venetoclax plus obinutuzumab combination treatment that is considered a standard first line treatment or receive sonrotoclax plus zanubrutinib. It is hypothesized that sonrotoclax plus zanubrutinib may be better than venetoclax plus obinutuzumab in treating CLL.
The main purpose of this study is to compare the duration the participants live without the CLL getting worse between participants who received sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab. Approximately 652 participants will be included in this study around the world. Participants will have equal chance to be allocated to receive either of the treatment combinations.
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
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 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
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
Note: Other protocol defined criteria may apply
Interventions
Sonrotoclax
DRUG
Zanubrutinib
DRUG
Venetoclax
DRUG
Obinutuzumab
DRUG
Locations
201
Australia (12)
Flinders Medical Centre
Bedford PK , South Australia
Pindara Private Hospital
Benowa , Queensland
Sunshine Coast Hospital and Health Service
Birtinya , Queensland
Monash Health
Clayton , Victoria
Concord Repatriation General Hospital
Concord , New South Wales
St Vincents Hospital Melbourne
Fitzroy , Victoria
Austin Health
Heidelberg , Victoria
Cabrini Hospital Malvern
Malvern East , Victoria
The Alfred Hospital
Melbourne , Victoria
Hollywood Private Hospital
Nedlands , Western Australia
Genesiscare North Shore
St Leonards , New South Wales
Princess Alexandra Hospital
Woolloongabba , Queensland
Austria (3)
Medizinische Universitatsklinik Innsbruck
Innsbruck
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
Salzburg
Hanusch Krankenhaus
Vienna
Brazil (6)
Unesp Faculdade de Medicina Da Universidade Estadual Paulista Campus Botucatu
Botucatu
Hospital Erasto Gaertner
Curitiba
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre
Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
Ribeirão Preto
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
São Paulo
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo
Canada (10)
Arthur Je Child Comprehensive Cancer Centre
Calgary , Alberta
Cross Cancer Institute
Edmonton , Alberta
Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre
Greenfield Park , Quebec
Centre Hospitalier de Luniversite de Montreal (Chum)
Montreal , Quebec
Lakeridge Health
Oshawa , Ontario
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec
Unite de Recherche Clinique Du Cisss Des Laurentides
SaintJerome , Quebec
Ciusss de Lestrie Chus
Sherbrooke , Quebec
Princess Margaret Cancer Centre
Toronto , Ontario
Cancercare Manitoba
Winnipeg , Manitoba
China (26)
Peking University Third Hospital
Beijing , Beijing Municipality
The First Peoples Hospital of Changzhou
Changzhou , Jiangsu
West China Hospital, Sichuan University
Chengdu , Sichuan
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu , Sichuan
Chongqing University Cancer Hospital
Chongqing , Chongqing Municipality
Fujian Medical University Union Hospital
Fuzhou , Fujian
Nanfang Hospital of Southern Medical University
Guangzhou , Guangdong
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou , Zhejiang
The First Affiliated Hospital of Anhui Medical University
Hefei , Anhui
Jieyang Peoples Hospital (Jieyang Affiliated Hospital, Sun Yat Sen University )
Jieyang , Guangdong
Shandong Provincial Hospital
Jinan , Shandong
Jining No1 Peoples Hospital West Branch
Jining , Shandong
The Second Affiliated Hospital of Nanchang University
Nanchang , Jiangxi
Jiangsu Province Hospital
Nanjing , Jiangsu
The First Affiliated Hospital of Guangxi Medical University
Nanning , Guangxi
Affiliated Hospital of Nantong University
Nantong , Jiangsu
Nanyang Central Hospital
Nanyang , Henan
The First Hospital of China Medical University
Shenyang , Liaoning
Institute of Hematology and Hospital of Blood Disease
Tianjin , Tianjin Municipality
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou , Zhejiang
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan , Hubei
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an , Shaanxi
The Affiliated Hospital of Xuzhou Medical University
Xuzhou , Jiangsu
Yantai Yuhuangding Hospital
Yantai , Shandong
Yichang Central Peoples Hospitaljiangnan Branch
Yichang , Hubei
Henan Cancer Hospital
Zhengzhou , Henan
Czech Republic (6)
Fakultni Nemocnice Brno
Brno
Fakultni Nemocnice Hradec Kralove
Hradec Králové
Fakultni Nemocnice Olomouc
Olomouc
Fakultni Nemocnice Ostrava
Ostrava
Fakultni Nemocnice Plzen
PLZE
Vseobecna Fakultni Nemocnice V Praze
Prague
France (13)
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux
Chu Clermont Ferrand Therapie Cellulaire and Hematolo
Clermontferrand
Clinique Louis Pasteur
Esseylesnancy
Centre Hospitalier Le Mans
Le Mans
Chu Lille
Lille
Centre Leon Berard
Lyon
Centre Hospitalier Universitaire Nantes Hotel Dieu
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