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NCT07277231PHASE3Recruiting

A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia

BeOne Medicines

Start Date

1/22/2026

Completion Date

11/1/2031

Summary

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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

DRUG

Sonrotoclax

DRUG

Zanubrutinib

DRUG

Acalabrutinib

DRUG

Venetoclax

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Conditions

Chronic Lymphocytic Leukemia

Locations

Stanford Cancer Institute

Palo Alto, California 94304-2205

United States

Northwestern University

Chicago, Illinois 60611

United States

Fred Hutchinson Cancer Research Center

Seattle, Washington 98109-4433

United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales NSW 2148

Australia

Concord Repatriation General Hospital

Concord, New South Wales NSW 2139

Australia

Genesiscare North Shore

St Leonards, New South Wales NSW 2065

Australia

Princess Alexandra Hospital

Woolloongabba, Queensland QLD 4102

Australia

Monash Health

Clayton, Victoria VIC 3168

Australia

Austin Health

Heidelberg, Victoria VIC 3084

Australia

Cabrini Hospital Malvern

Malvern, Victoria VIC 3144

Australia

The Alfred Hospital

Melbourne, Victoria VIC 3004

Australia

Instituto Dor de Pesquisa E Ensino Distrito Federal

Brasília, 70390140

Brazil

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, 90110-270

Brazil

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, 01401-004

Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, 05652-900

Brazil

Bc Cancer Victoria

Victoria, British Columbia V8R 6V5

Canada

Juravinski Cancer Centre

Hamilton, Ontario L8V 5C2

Canada

Ciusss Nim Hscm

Montreal, Quebec H4J 1C5

Canada

Jewish General Hospital

Montreal, Quebec QC H3t 1E2

Canada

Ciusss de Lestrie Chus

Sherbrooke, Quebec J1H 5N4

Canada

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

Québec, G1J 1Z4

Canada

Peking Union Medical College Hospital

Beijing, Beijing Municipality 100730

China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality 630014

China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian 350005

China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong 510000

China

Sun Yat Sen University Cancer Center Huangpu Branch

Guangzhou, Guangdong 510555

China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi 530021

China

Guizhou Provincial Peoples Hospital

Guiyang, Guizhou 550002

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang 150000

China

Henan Cancer Hospital

Zhengzhou, Henan 450000

China

The Second Xiangya Hospital of Central South University

Changsha, Hunan 410011

China

Jiangsu Province Hospital

Nanjing, Jiangsu 210029

China

Affiliated Hospital of Nantong University

Nantong, Jiangsu 201203

China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi 330006

China

The Second Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi 710004

China

Shandong Provincial Hospital

Jinan, Shandong 250000

China

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality 200025

China

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

Chengdu, Sichuan 610071

China

Institute of Hematology and Hospital of Blood Disease

Tianjin, Tianjin Municipality 300020

China

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan 650032

China

The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

Hangzhou, Zhejiang 310002

China

Fakultni Nemocnice Brno

Brno, 625 00

Czechia

Fakultni Nemocnice Hradec Kralove

Hradec Králové, 500 03

Czechia

Fakultni Nemocnice Olomouc

Olomouc, 77900

Czechia

Fakultni Nemocnice Ostrava

Ostrava, 708 00

Czechia

Fakultni Nemocnice Plzen

PLZE, 323 00

Czechia

Vseobecna Fakultni Nemocnice V Praze

Prague, 10000

Czechia

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, 33000

France

Chu Clermont Ferrand Therapie Cellulaire and Hematolo

ClermontFerrand, 63100

France

Centre Hospitalier Le Mans

Le Mans, 72037

France

Hopital Claude Huriez Chu Lille

Lille, 59000

France

Centre Leon Berard

Lyon, 69373

France

Chu Montpellier Hopital Saint Eloi

Montpellier, 34090

France

Iuc Toulouse Oncopole

Toulouse, 31100

France

Donauisar Klinikum Deggendorf Klinik Fur Onkologie Und Hamatologie

Deggendorf, 94469

Germany

Centrum Fur Haematologie Und Onkologie Bethanien

Frankfurt am Main, 60389

Germany

Klinikum St Elisabeth Straubing Gmbh Mvz Klinikum Straubing Gmbh

Straubing, 94315

Germany

Irccs Azienda Ospedaliero Universitaria Bologna

Bologna, 40138

Italy

Aou Careggi, Servizio Sanitario Toscana

Florence, 50134

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Azienda Ospedaliera Di Padova

Padova, 35128

Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168

Italy

Flevoziekenhuis

Almere Stad, 1315 RA

Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, 3318 AT

Netherlands

Hagaziekenhuis

Sgravenhage, 2545 AA

Netherlands

North Shore Hospital

Auckland, 0622

New Zealand

Auckland City Hospital

Auckland, 1023

New Zealand

Health New Zealand Canterbury

Christchurch, 8011

New Zealand

Dunedin Hospital

Dunedin, 9016

New Zealand

Wellington Regional Hospital (Ccdhb)

Wellington, 6021

New Zealand

Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny

Brzozów, 36-200

Poland

Pratia Onkologia Katowice

Katowice, 40-519

Poland

Pratia McM Krakow

Krakow, 30-727

Poland

Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

Lublin, 20-090

Poland

Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

Wroclaw, 50-367

Poland

Coltea Clinical Hospital

Bucharest, 30171

Romania

Institutul Clinic Fundeni

Bucureti, 022328

Romania

Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca

ClujNapoca, 400015

Romania

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620

South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi 06591

South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi 03722

South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi 03080

South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi 05505

South Korea

Hospital Universitario Virgen de Las Nieves

Granada, 18014

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, 28222

Spain

Hospital Clinico Universitario Virgen de La Arrixaca

Murcia, 30120

Spain

Karolinska Universitetssjukhuset Solna

Stockholm, 171 76

Sweden

University Hospitals Dorset Royal Bournemouth Hospital

Bournemouth, BH7 7DW

United Kingdom

Kings College Hospital

London, SE5 9RS

United Kingdom

Norfolk and Norwich University Hospitals Nhs Foundation Trust

Norwich, NR4 7UY

United Kingdom