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(24)

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 East, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, Brazil

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, Brazil

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

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

North Shore Hospital

Auckland, New Zealand

Auckland City Hospital

Auckland, New Zealand

Wellington Regional Hospital (Ccdhb)

Wellington, New Zealand

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

Kings College Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07277231

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