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ACTIVE NOT RECRUITING
NCT06073821
PHASE3

Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)

Sponsor: BeOne Medicines

View on ClinicalTrials.gov

Summary

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)

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

652

Start Date

2023-11-11

Completion Date

2032-12

Last Updated

2026-03-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

Sonrotoclax

Administered orally

DRUG

Zanubrutinib

Administered orally

DRUG

Venetoclax

Administered orally

DRUG

Obinutuzumab

Administered intravenously

Locations (201)

Alaska Oncology and Hematology, Llc

Anchorage, Alaska, United States

City of Hope National Medical Center

Duarte, California, United States

University of California San Diego (Ucsd) Moores Cancer Center

La Jolla, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

UCLA Department of Medicine Hematologyoncology

Los Angeles, California, United States

Chao Family Comprehensive Cancer Center

Orange, California, United States

Stanford Medicine

Palo Alto, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Southeastern Regional Medical Center

Newnan, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Illinois Cancercare, Pc

Peoria, Illinois, United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Mission Cancer and Blood

Waukee, Iowa, United States

The University of Kansas Cancer Center

Westwood, Kansas, United States

Norton Cancer Institute Pavilion

Louisville, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

John Theurer Cancer Center Hackensack University Medical Center

Hackensack, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Columbia University Medical Center

New York, New York, United States

Clinical Research Alliance, Inc

Westbury, New York, United States

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina, United States

Atrium Health Levine Cancer Institute (Lci)

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

The James Cancer Hospital and Solove Research Institute At Ohio State University

Columbus, Ohio, United States

Oncology Associates of Oregon Willamette Valley Cancer Center

Eugene, Oregon, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Scri Tennessee Oncology Chattanooga

Chattanooga, Tennessee, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Virginia Cancer Institute

Richmond, Virginia, United States

Vcu Health Systemmassey Comprehensive Cancer Center

Richmond, Virginia, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Gunderson Health System

La Crosse, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Genesiscare North Shore

St Leonards, New South Wales, Australia

Pindara Private Hospital

Benowa, Queensland, Australia

Sunshine Coast Hospital and Health Service

Birtinya, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Flinders Medical Centre

Bedford PK, South Australia, Australia

Monash Health

Clayton, Victoria, Australia

St Vincents Hospital Melbourne

Fitzroy, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Cabrini Hospital Malvern

Malvern East, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Hollywood Private Hospital

Nedlands, Western Australia, Australia

Medizinische Universitatsklinik Innsbruck

Innsbruck, Austria

Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg

Salzburg, Austria

Hanusch Krankenhaus

Vienna, Austria

Unesp Faculdade de Medicina Da Universidade Estadual Paulista Campus Botucatu

Botucatu, Brazil

Hospital Erasto Gaertner

Curitiba, Brazil

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, Brazil

Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp

Ribeirão Preto, Brazil

Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular

São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

Arthur Je Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

Cancercare Manitoba

Winnipeg, Manitoba, Canada

Lakeridge Health

Oshawa, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre

Greenfield Park, Quebec, Canada

Centre Hospitalier de Luniversite de Montreal (Chum)

Montreal, Quebec, Canada

Unite de Recherche Clinique Du Cisss Des Laurentides

SaintJerome, Quebec, Canada

Ciusss de Lestrie Chus

Sherbrooke, Quebec, Canada

Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)

Québec, Canada

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Jieyang Peoples Hospital (Jieyang Affiliated Hospital, Sun Yat Sen University )

Jieyang, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Nanyang Central Hospital

Nanyang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Yichang Central Peoples Hospitaljiangnan Branch

Yichang, Hubei, China

The First Peoples Hospital of Changzhou

Changzhou, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

The Second Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Shandong Provincial Hospital

Jinan, Shandong, China

Jining No1 Peoples Hospital West Branch

Jining, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

Chengdu, Sichuan, China

Institute of Hematology and Hospital of Blood Disease

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Fakultni Nemocnice Brno

Brno, Czechia

Fakultni Nemocnice Hradec Kralove

Hradec Králové, Czechia

Fakultni Nemocnice Olomouc

Olomouc, Czechia

Fakultni Nemocnice Ostrava

Ostrava, Czechia

Fakultni Nemocnice Plzen

PLZE, Czechia

Vseobecna Fakultni Nemocnice V Praze

Prague, Czechia

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, France

Chu Clermont Ferrand Therapie Cellulaire and Hematolo

Clermontferrand, France

Clinique Louis Pasteur

Esseylesnancy, France

Centre Hospitalier Le Mans

Le Mans, France

Chu Lille

Lille, France

Centre Leon Berard

Lyon, France

Centre Hospitalier Universitaire Nantes Hotel Dieu

Nantes, France

Hopital Prive Du Confluent

Nantes, France

Hopital de La Pitie Salpetriere

Paris, France

Chu Rennes

Rennes Cedes, France

Centre Henri Becquerel

Rouen, France

Chu Tours Hopital Bretonneau

Tours, France

Chu Nancy Hopital Brabois

VandoeuvrelesNancy, France

Praxis Am Volkspark

Berlin, Germany

Centrum Fur Haematologie Und Onkologie Bethanien

Frankfurt am Main, Germany

Universitaetsklinikum Schleswig Holstein Campus Luebeck

Lübeck, Germany

Assuta Ashdod Medical Center

Ashdod, Israel

Carmel Medical Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Hadassah University Hospital Ein Kerem

Jerusalem, Israel

Assuta Medical Center

Tel Aviv, Israel

Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi

Bologna, Italy

Azienda Ospedaliero Universitaria Di Ferrara

Ferrara, Italy

Istituto Europeo Di Oncologia

Milan, Italy

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, Italy

Aou Maggiore Della Carita

Novara, Italy

Azienda Ospedaliera Di Padova

Padova, Italy

Ospedale Santa Maria Della Misericordia

Perugia, Italy

Aichi Cancer Center Hospital Clinical Oncology

Nagoya, Aichi-ken, Japan

Chiba Cancer Center

Chiba, Chiba, Japan

Nho Shikoku Cancer Center

Matsuyama, Ehime, Japan

Aiiku Hospital

Sapporo, Hokkaido, Japan

Hyogo Prefectural Amagasaki General Medical Center

AmagasakiCity, Hyōgo, Japan

Kagoshima University Hospital

Kagoshima, Kagoshima-ken, Japan

Tokai University Hospital

Iseharashi, Kanagawa, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Niigata University Medical and Dental Hospital

Niigata, Niigata, Japan

Kurashiki Central Hospital

Kurashikishi, Okayama-ken, Japan

Kansai Medical University Hospital

Hirakata, Osaka, Japan

Kindai University Hospital

Sakai, Osaka, Japan

National Cancer Center Hospital

ChuoKu, Tokyo, Japan

Yamagata University Hospital

Yamagata, Yamagata, Japan

Aomori Prefectural Central Hospital

Aomori, Japan

Kumamoto University Hospital

Kumamoto, Japan

National Hospital Organization Okayama Medical Center

Okayama, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Yokohama Municipal Citizens Hospital

Yokohama, Japan

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Flevoziekenhuis

Almere Stad, Netherlands

Meander Medisch Centrum

Amersfoort, Netherlands

Amsterdam Umc Vu Mc

Amsterdam, Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, Netherlands

Martini Ziekenhuis

Groningen, Netherlands

Ikazia Ziekenhuis

Rotterdam, Netherlands

Franciscus Gasthuis and Vlietland

Schiedam, Netherlands

Hagaziekenhuis

Sgravenhage, Netherlands

North Shore Hospital

Auckland, New Zealand

Auckland City Hospital

Auckland, New Zealand

Christchurch Hospital

Christchurch, New Zealand

Dunedin Hospital

Dunedin, New Zealand

Tauranga Hospital

Tauranga, New Zealand

Wellington Regional Hospital (Ccdhb)

Wellington, New Zealand

Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

Lodz, Poland

Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

Lublin, Poland

Uniwersytecki Szpital Kliniczny W Poznaniu

Poznan, Poland

Centralny Szpital Kliniczny Uck Wum

Warsaw, Poland

Instytut Hematologii I Transfuzjologii

Warsaw, Poland

Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

Wroclaw, Poland

Auxilio Mutuo Cancer Center

San Juan, Puerto Rico

National Cancer Center (Korea)

IlsandongGu GoyangSi, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea

Hospital Universitario de Burgos

Burgos, Spain

Institut Catala Doncologia Hospital Duran I Reynals

L'Hospitalet de Llobregat, Spain

Hospital Universitario de Gran Canaria Dr Negrin

Las Palmas de Gran Canaria, Spain

Md Anderson Cancer Center Madrid Spain

Madrid, Spain

Hospital Universitario Ramon Y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital La Candelaria

Santa Cruz de Tenerife, Spain

Karolinska Universitetssjukhuset Solna

Stockholm, Sweden

Ankara University Medical Faculty

Ankara, Turkey (Türkiye)

Gazi University

Ankara, Turkey (Türkiye)

Erciyes University School of Medicine

Kayseri, Turkey (Türkiye)

Kocaeli Universitesi Tip Fakultesi

Kocaeli, Turkey (Türkiye)

University Hospitals Dorset Royal Bournemouth Hospital

Bournemouth, United Kingdom

Kent and Canterbury Hospital

Canterbury, United Kingdom

Oxford University Hospitals Nhs Trust Churchill Hospital

Headington, United Kingdom

St Jamess University Hospital

Leeds, United Kingdom

The Clatterbridge Cancer Centre Liverpool

Liverpool, United Kingdom

University College Hospital

London, United Kingdom

Kings College

London, United Kingdom

Norfolk and Norwich University Hospitals Nhs Foundation Trust

Norwich, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

Royal Marsden Nhs Foundation Royal Marsden Hospital

Sutton, United Kingdom