Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07277231

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

Led by BeOne Medicines · Updated on 2026-05-11

500

Participants Needed

29

Research Sites

301 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with confirmed chronic lymphocytic leukemia requiring treatment
  • No prior treatment for CLL
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Measurable disease by CT or MRI scans
  • Adequate bone marrow and organ function
Not Eligible

You will not qualify if you...

  • Previous systemic treatment for chronic lymphocytic leukemia
  • Known prolymphocytic leukemia or history or suspicion of Richter's transformation
  • Known involvement of the central nervous system
  • History of progressive multifocal leukoencephalopathy (PML)
  • Uncontrolled high blood pressure or significant cardiovascular disease
  • Other protocol-defined exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 29 locations

1

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia, NSW 2148

Actively Recruiting

2

Concord Repatriation General Hospital

Concord, New South Wales, Australia, NSW 2139

Actively Recruiting

3

Genesiscare North Shore

St Leonards, New South Wales, Australia, NSW 2065

Actively Recruiting

4

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, QLD 4102

Actively Recruiting

5

Monash Health

Clayton, Victoria, Australia, VIC 3168

Actively Recruiting

6

Austin Health

Heidelberg, Victoria, Australia, VIC 3084

Actively Recruiting

7

Cabrini Hospital Malvern

Malvern East, Victoria, Australia, VIC 3144

Actively Recruiting

8

The Alfred Hospital

Melbourne, Victoria, Australia, VIC 3004

Actively Recruiting

9

Instituto Dor de Pesquisa E Ensino Distrito Federal

Brasília, Brazil, 70390140

Actively Recruiting

10

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, Brazil, 90110-270

Actively Recruiting

11

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, Brazil, 01401-004

Actively Recruiting

12

Ciusss Nim Hscm

Montreal, Quebec, Canada, H4J 1C5

Actively Recruiting

13

Jewish General Hospital

Montreal, Quebec, Canada, QC H3t 1E2

Actively Recruiting

14

Ciusss de Lestrie Chus

Sherbrooke, Quebec, Canada, J1H 5N4

Actively Recruiting

15

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

Québec, Canada, G1J 1Z4

Actively Recruiting

16

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510000

Actively Recruiting

17

Jiangsu Province Hospital

Nanjing, Jiangsu, China, 210029

Actively Recruiting

18

The Second Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China, 710004

Actively Recruiting

19

North Shore Hospital

Auckland, New Zealand, 0622

Actively Recruiting

20

Auckland City Hospital

Auckland, New Zealand, 1023

Actively Recruiting

21

Health New Zealand Canterbury

Christchurch, New Zealand, 8011

Actively Recruiting

22

Wellington Regional Hospital (Ccdhb)

Wellington, New Zealand, 6021

Actively Recruiting

23

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea, 13620

Actively Recruiting

24

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, South Korea, 06591

Actively Recruiting

25

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722

Actively Recruiting

26

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea, 03080

Actively Recruiting

27

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea, 05505

Actively Recruiting

28

University Hospitals Dorset Royal Bournemouth Hospital

Bournemouth, United Kingdom, BH7 7DW

Actively Recruiting

29

Kings College Hospital

London, United Kingdom, SE5 9RS

Actively Recruiting

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Research Team

S

Study Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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