Active not recruitingPHASE3INTERVENTIONAL

A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL

This research study is looking at a new medicine called zanubrutinib for people who have not yet received treatment for Chronic Lymphocytic Leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL). The study aims to compare how well zanubrutinib works against a common combination of medicines, bendamustine and rituximab. In some cases, zanubrutinib might also be combined with another drug called venetoclax. The main goal is to find out which treatment is better at keeping the cancer from progressing. This is a large study involving many people and is an important step in understanding the best ways to treat these conditions for future patients. It will also help doctors understand if certain genetic changes, like del(17p), affect how well treatments work.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

BeiGene

Enrolment target

590

Start

31 Oct 2017

Estimated completion

31 Oct 2027

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Results

Results from this study

Posted November 2023

Results have been published for this study.

Primary outcome

Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR)

PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the ICR per 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines with modifications for treatment-related lymphocytosis in participants with CLL and the Revised Criteria for Response for Malignant Lymphoma in participants with small lymphocytic lymphoma (SLL).

Full results on the registry

What is this study about?

This research study is about finding better treatments for two types of cancer called Chronic Lymphocytic Leukaemia (CLL) and Small Lymphocytic Lymphoma (SLL). These conditions affect certain types of white blood cells. If you have been diagnosed with CLL or SLL and haven't had treatment for it yet, this study might be for you. The main purpose is to compare a newer drug called zanubrutinib with a standard treatment often used for these conditions, which is a combination of two drugs: bendamustine and rituximab. We want to see which treatment is more effective at preventing the cancer from getting worse or coming back.

The study will involve different groups of patients. Some will receive zanubrutinib, others will receive bendamustine plus rituximab. Thereâ€™s also a group looking at zanubrutinib combined with another drug called venetoclax. This is a 'Phase 3' study, which means it's a large, important trial that helps confirm if a new treatment is better than existing ones. We're also looking closely at whether certain genetic changes in your cancer cells make a difference to how you respond to the treatments.

Understanding how these different treatments work and who they work best for is crucial. The information gathered from this study will help doctors make more informed decisions about the best course of treatment for people with CLL and SLL in the future. It's about ensuring patients have access to the most effective and safe options available.

Key takeaways

New study for those with previously untreated CLL or SLL.
Compares zanubrutinib with standard treatments.
Aims to find more effective ways to stop cancer progression.
Open to adults aged 18 and over.
Participation involves regular checks and specific medication.
You can leave the study at any time.

Who may be eligible?

This study is looking for adults aged 18 or over who have been newly diagnosed with Chronic Lymphocytic Leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL) and need treatment for it, but are not suitable for a specific type of strong chemotherapy called FCR. You would also need to have cancer that can be measured, generally good health otherwise, and a life expectancy of at least six months. Your body functions, like your bone marrow, kidneys, and liver, need to be working adequately.

There are several reasons why someone might not be able to join. For example, if you've already had treatment for CLL or SLL, or if you have certain other serious health issues like heart problems, uncontrolled infections, or another recent cancer diagnosis (unless it was a very common and easily treated skin or bladder cancer). You also couldn't join if you are pregnant or breastfeeding, or if you've had a stroke or major bleeding problem recently. The medical team will check details like your ability to swallow capsules and if you take any medications that might interfere with the study drugs. They will also check genetic markers.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with CLL or SLL and not yet treated for it?
Are you generally in good health, apart from your CLL/SLL?
Do you have adequate organ function (kidneys, liver, bone marrow)?
Are you able to swallow capsules?
Have you had no other recent cancers (except some common, treated types)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of several treatment groups, meaning you won't choose which treatment you receive. You will receive either zanubrutinib, or bendamustine plus rituximab, or zanubrutinib plus venetoclax. The study is 'open-label', which means both you and your study doctor will know which treatment you are receiving. You will have regular visits to the hospital or clinic for assessments, which will include blood tests, physical examinations, and scans to monitor your health and how the treatment is working. The study drugs will be provided to you. The total length of your participation will depend on how you respond to the treatment, but it will involve ongoing follow-up to track your health and how your cancer is responding. The study aims to follow participants as long as the treatment is benefiting them or until a certain point in time if the treatment needs to be stopped for other reasons.

Potential risks and benefits

Taking part in this study might offer you access to a new treatment (zanubrutinib) before it's widely available. There's a chance that this treatment could be more effective for your cancer than standard options, or it could lead to a better quality of life. However, like all medicines, the treatments in this study have potential side effects. These can range from mild to severe, and they will be carefully monitored by the study team. You will be fully informed about all known risks before you make a decision. There is also no guarantee that the treatment will work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (158)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Augusta University
Verified postcode
Augusta, United States
Northwestern University
Verified postcode
Chicago, United States
Dana Farber Cancer Institute
Verified postcode
Boston, United States
Research Medical Center
Verified postcode
Kansas City, United States
Washington University
Verified postcode
St Louis, United States
Comprehensive Cancer Centers of Nevada
Verified postcode
Las Vegas, United States
Summit Medical Group
Verified postcode
Florham Park, United States
Icahn School of Medicine At Mount Sinai
Verified postcode
New York, United States
Columbia University Medical Center
Verified postcode
New York, United States
University of Rochester
Verified postcode
Rochester, United States
Duke University
Verified postcode
Durham, United States
Oregon Health and Science University
Verified postcode
Portland, United States

Common questions

What is CLL and SLL?

CLL (Chronic Lymphocytic Leukaemia) and SLL (Small Lymphocytic Lymphoma) are slow-growing cancers that affect a type of white blood cell called lymphocytes. They are very similar, just found in different parts of the body.

What is zanubrutinib?

Zanubrutinib is a newer targeted cancer drug that aims to stop cancer cells from growing and surviving by blocking specific signals within them.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, which means both you and your study doctor will know which treatment you are receiving.

What is 'progression-free survival'?

Progression-free survival means the length of time that a patient lives with the cancer but the disease does not get worse. This is a common way to measure how well a cancer treatment works.

Can I stop participating in the study at any time?

Yes, you are completely free to withdraw from the study at any point, and your decision will not affect your ongoing medical care.