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Looking for participantsPhase3

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

Sponsor: BeOne Medicines

NCT ID: NCT07277231

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sonrotoclax (drug), Zanubrutinib (drug), Acalabrutinib (drug), Venetoclax (drug)
How long the study runs
Study runs about 70 months (dates as stated)
About the drug or intervention
Sonrotoclax — drug: Administered orally. · Zanubrutinib — drug: Administered orally. · Acalabrutinib — drug: Administered orally. · Venetoclax — drug: Administered orally.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
500
Started
2026-01-22
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for chronic lymphocytic leukemia
  • • Phase3 - 500 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with chronic lymphocytic leukemia

Where?

  • • Birmingham - Queen Elizabeth Hospital
  • • Bournemouth - University Hospitals Dorset Royal Bournemouth Hospital
  • • Leeds - St Jamess University Hospital
  • • London - Kings College Hospital
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Chronic Lymphocytic Leukemia

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ treatment

What the study is looking for

  • ✓Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment
  • ✓activity scale (ECOG) score 0, 1, or 2
  • ✓cancer that can be measured on scans by Computer Tomography/Magnetic Resonance Imaging
  • ✓Adequate bone marrow and organ health

Who cannot take part

  • ✗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
See the full criteria
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.

Where Is This Study? (5 UK sites)

Queen Elizabeth Hospital

Birmingham B15 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Tom Dymond

research&development@qehkl.nhs.uk01553 613532

University Hospitals Dorset Royal Bournemouth Hospital

Bournemouth BH7 7DW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Louise Bell

uhd.researchoffice@nhs.net0300 019 8500

St Jamess University Hospital

Leeds LS9 7TF, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

Kings College Hospital

London SE5 9RS, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

Norfolk and Norwich University Hospitals Nhs Foundation Trust

Norwich NR4 7UY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Julie Dawson

rdsubmissions@nnuh.nhs.uk01603 286611

How to Get in Touch

Study Director

Sponsor contact

CONTACT

8778285568 clinicaltrials@beonemed.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09