RecruitingPHASE3INTERVENTIONAL

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

If you're an adult living in the UK and have just been diagnosed with Chronic Lymphocytic Leukemia (CLL) and need treatment, you might be interested in a new clinical trial. This study is testing two different combinations of medicines: one group will receive sonrotoclax and zanubrutinib, and the other will receive venetoclax and acalabrutinib. Both combinations are a fixed length, meaning you'll take them for a set period, not indefinitely. Researchers want to find out which combination works best and is safest for people who haven't had treatment for CLL before. This is an important step in finding better treatments for CLL.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

BeOne Medicines

Enrolment target

500

Start

22 Jan 2026

Estimated completion

01 Nov 2031

Chronic Lymphocytic Leukemia

What is this study about?

This study is designed for adults in the UK who have recently been diagnosed with a type of blood cancer called Chronic Lymphocytic Leukemia, or CLL. CLL affects white blood cells, and while it often grows slowly, some people need treatment. This particular trial is for those who haven't received any treatment for their CLL yet. It's a 'Phase 3' study, which means it's one of the final stages of testing, comparing new treatments with existing ones or other promising combinations.

The main goal of this study is to compare two different treatment plans. One plan involves taking two medicines called sonrotoclax and zanubrutinib together. The other plan uses a different pair of medicines: venetoclax and acalabrutinib. Both of these treatment plans are for a set amount of time – they're not treatments you'd continue indefinitely. By comparing them, doctors hope to learn which combination is more effective at treating CLL and which has fewer side effects, ultimately aiming to improve care for people with this condition.

Taking part in a study like this helps improve our understanding of CLL and leads to new and better ways to treat it. It's a chance to potentially receive new treatments under close medical supervision. The results from this study will help doctors decide on the best treatment options for future patients with CLL.

Key takeaways

It's for adults newly diagnosed with Chronic Lymphocytic Leukemia (CLL) who haven't had treatment before.
The study compares two different drug combinations: sonrotoclax + zanubrutinib vs. venetoclax + acalabrutinib.
Treatments are given for a set period, not indefinitely.
It's a Phase 3 study, meaning it's in the later stages of testing new treatments.
Participation involves regular health checks, tests, and follow-up.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be an adult from the UK and have been diagnosed with CLL for the first time, meaning you haven't had any treatment for it before. It's important that your CLL requires treatment. Your general health will also be checked; for example, doctors will look at your overall fitness level and how well your major organs are working.

There are also some reasons why you wouldn't be able to join. If you've already had medicine for your CLL, or if you have certain other specific health conditions, like some other types of blood cancers, severe high blood pressure that isn't under control, or specific heart problems, you wouldn't be able to take part. The study also can't include people with certain brain or nerve conditions.

The research team will carry out detailed checks to make sure the study is right for you and that you meet all the necessary health requirements to participate safely.

Quick self-check

Are you an adult aged 18 or over?
Have you recently been diagnosed with CLL and need treatment?
Have you never received any treatment for your CLL before?
Are you generally feeling well and active (as assessed by your doctor)?
Do you have suitable organ function (as assessed by your doctor)?
Do you *not* have certain other specific health conditions, such as uncontrolled high blood pressure or certain heart problems?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will receive one of two specific drug combinations for a set period. This means you won't be on the treatment indefinitely. You will have regular visits to the clinic for health checks, blood tests, and scans (like CT or MRI scans) to monitor your CLL and how you're reacting to the medication. These visits are important for keeping a close eye on your health and the treatment's effectiveness. The doctors will also check for any side effects you might experience. After your treatment period, there will be follow-up appointments to see how you are doing in the longer term. The total duration of your involvement, including follow-up, will be explained by the study team.

Potential risks and benefits

Taking part in this study could offer several potential benefits, such as receiving state-of-the-art treatments for your CLL under close medical supervision and contributing to medical science. However, like all medications, the drugs used in this study may have side effects, which the study team will discuss with you in detail. There's also no guarantee that the treatment will work for everyone, or that it will be better than standard care. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (66)

Fred Hutchinson Cancer Research Center
Seattle, United States· Recruiting
Blacktown Cancer and Haematology Centre
Blacktown, Australia· Recruiting
Concord Repatriation General Hospital
Concord, Australia· Recruiting
Genesiscare North Shore
St Leonards, Australia· Recruiting
Princess Alexandra Hospital
Woolloongabba, Australia· Recruiting
Monash Health
Clayton, Australia· Recruiting
Austin Health
Heidelberg, Australia· Recruiting
Cabrini Hospital Malvern
Malvern, Australia· Recruiting
The Alfred Hospital
Melbourne, Australia· Recruiting
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasília, Brazil· Recruiting
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, Brazil· Recruiting
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil· Recruiting

+54 more sites — see the official record for the full list.

Common questions

What is CLL?

CLL stands for Chronic Lymphocytic Leukemia. It's a slow-growing cancer that affects a type of white blood cell called lymphocytes.

Why is this study important?

This study aims to find better and safer treatments for people newly diagnosed with CLL by comparing two different drug combinations.

Will I know which treatment I'm getting?

Often in studies like this, you won't know which specific drug combination you're receiving (this is called 'blinding') to ensure fair comparison of results. The study team will explain how this works.

How long will I be on the treatment?

The treatments in this study are for a 'fixed duration,' meaning you will take them for a set period of time, not indefinitely. The exact length will be discussed with you.

Can I stop participating if I want to?

Yes, absolutely. Your participation is completely voluntary, and you can withdraw from the study at any time without having to give a reason, and it won't affect your future medical care.

How to find out more

Study Director

clinicaltrials@beonemed.com 8778285568 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.