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), Obinutuzumab (drug), Rituximab (drug), Venetoclax (drug)
- How long the study runs
- Study runs about 78 months (dates as stated)
- About the drug or intervention
- Sonrotoclax — drug: Administered orally · Obinutuzumab — drug: Administered intravenously · Rituximab — drug: Administered intravenously · Venetoclax — drug: Administered Orally
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at whether combining sonrotoclax with obinutuzumab, or sonrotoclax with rituximab, works better than venetoclax with rituximab at slowing down chronic lymphocytic leukaemia or small lymphocytic lymphoma that has come back or not responded to treatment. It measures how long patients live without their disease getting worse (progression-free survival). The study is sponsored by BeOne Medicines.
Who can take part
- Confirmed diagnosis of chronic lymphocytic leukaemia or small lymphocytic lymphoma
- Have already had at least one previous treatment, with at least 2 cycles of each treatment
- May have had a previous BCL2 inhibitor medicine if the disease stayed away for at least 3 years and it has been at least 2 years since the last dose
- Able to carry out day-to-day activities (performance status score of 0, 1 or 2)
- Healthy enough organs (such as liver and kidneys)
Who may not be able to
- A type of leukaemia called prolymphocytic leukaemia that is active, or a suspected Richter's transformation
- A stem cell transplant using your own cells or CAR T-cell therapy (a treatment using changed immune cells) within 3 months before the first study dose
- A stem cell transplant from a donor with active graft-versus-host disease, needing drugs to suppress the immune system for it, or having taken calcineurin inhibitor drugs within 4 weeks before agreeing to take part
- Chronic lymphocytic leukaemia or small lymphocytic lymphoma that has spread to the brain or spinal cord
- Severe or disabling lung disease
- Serious heart disease
What taking part involves
- • Taking sonrotoclax with obinutuzumab, or sonrotoclax with rituximab, compared with venetoclax plus rituximab
Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 630
- Started
- 2025-06-11
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for chronic lymphocytic leukemia
- • Phase3 - 630 participants
- • The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with chronic lymphocytic leukemia
Where?
- • Bournemouth - University Hospitals Dorset Royal Bournemouth Hospital
- • Headington - Oxford University Hospitals Nhs Trust Churchill Hospital
- • Leeds - St Jamess University Hospital
- • London - Kings College Hospital
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.
More detail
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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:
- ✓ received at least 2 cycles of the therapy
What the study is looking for
- ✓Confirmed diagnosis of CLL/SLL that meets the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
- ✓Received one or more prior therapies for CLL/SLL. For each line of therapy, participants must have received at least...
- ✓Participants with prior BCL2i exposure are eligible if remission duration was ≥3 years with ≥2 years from last BCL2i...
- ✓activity scale (ECOG) Performance Status score of 0, 1, or 2
- ✓healthy organ
Who cannot take part
- ✗Known active prolymphocytic leukemia or currently suspected Richter's transformation
- ✗Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first...
- ✗Known central nervous system involvement by CLL/SLL
- ✗Severe or debilitating lung disease
- ✗Clinically significant cardiovascular disease
See the full criteria
Where Is This Study? (7 UK sites)
University Hospitals Dorset Royal Bournemouth Hospital
Bournemouth BH7 7DW, United Kingdom
Oxford University Hospitals Nhs Trust Churchill Hospital
Headington OX3 7LE, United Kingdom
St Jamess University Hospital
Leeds LS9 7TF, United Kingdom
Kings College Hospital
London SE5 9RS, United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral CH63 4JY, United Kingdom
Freeman Hospital
Newcastle upon Tyne NE7 7DN, United Kingdom
Royal Cornwall Hospitalsnhs Trust
Truro TR1 3LJ, United Kingdom
How to Get in Touch
Study Director
Sponsor contactCONTACT