RecruitingPhase 3NCT07277231

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

A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Sponsor

BeOne Medicines

Enrollment

500 participants

Start Date

Jan 22, 2026

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two new drug combinations for previously untreated chronic lymphocytic leukemia (CLL) — a slow-growing blood cancer. One combination uses sonrotoclax plus zanubrutinib, and the other uses venetoclax plus acalabrutinib, to see which works better. **You may be eligible if...** - You are an adult newly diagnosed with CLL that now requires treatment - You have never received systemic treatment for CLL before - Your disease is measurable on scan - You are in reasonably good health (ECOG 0–2) - Your bone marrow and organ function are adequate **You may NOT be eligible if...** - You have previously received any systemic treatment for CLL - You have prolymphocytic leukemia or Richter's transformation (CLL that has changed into a more aggressive cancer) - Cancer has spread to the brain or spinal fluid - You have a history of a rare brain infection called PML - You have uncontrolled high blood pressure or significant heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSonrotoclax

Administered orally.

DRUGZanubrutinib

Administered orally.

DRUGAcalabrutinib

Administered orally.

DRUGVenetoclax

Administered orally.

Locations(66)

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Genesiscare North Shore

St Leonards, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Monash Health

Clayton, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Cabrini Hospital Malvern

Malvern, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Instituto Dor de Pesquisa E Ensino Distrito Federal

Brasília, Brazil

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, Brazil

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, Brazil

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Ciusss Nim Hscm

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, 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

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Guizhou Provincial Peoples Hospital

Guiyang, Guizhou, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The Second Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 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

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Fakultni Nemocnice Ostrava

Ostrava, Czechia

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, France

Chu Clermont Ferrand Therapie Cellulaire and Hematolo

ClermontFerrand, France

Centre Hospitalier Le Mans

Le Mans, France

Hopital Claude Huriez Chu Lille

Lille, France

Centre Leon Berard

Lyon, France

Chu Montpellier Hopital Saint Eloi

Montpellier, France

Iuc Toulouse Oncopole

Toulouse, France

Donauisar Klinikum Deggendorf Klinik Fur Onkologie Und Hamatologie

Deggendorf, Germany

Aou Careggi, Servizio Sanitario Toscana

Florence, Italy

Ospedale San Raffaele

Milan, Italy

Azienda Ospedaliera Di Padova

Padova, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy

North Shore Hospital

Auckland, New Zealand

Auckland City Hospital

Auckland, New Zealand

Health New Zealand Canterbury

Christchurch, New Zealand

Dunedin Hospital

Dunedin, New Zealand

Wellington Regional Hospital (Ccdhb)

Wellington, New Zealand

Pratia Onkologia Katowice

Katowice, Poland

Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

Lublin, Poland

Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

Wroclaw, Poland

Institutul Clinic Fundeni

Bucureti, Romania

Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca

ClujNapoca, Romania

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 Virgen de Las Nieves

Granada, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

Hospital Clinico Universitario Virgen de La Arrixaca

Murcia, Spain

University Hospitals Dorset Royal Bournemouth Hospital

Bournemouth, United Kingdom

Kings College Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07277231

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