Active not recruitingPHASE3INTERVENTIONAL

Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)

This study is for people with chronic lymphocytic leukaemia (CLL), a type of blood cancer, who haven't received treatment yet. CLL can cause swollen lymph nodes, spleen, or liver, and symptoms like night sweats and weight loss. This research aims to find better ways to help people live longer and feel better. We are comparing two treatment combinations: sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab. The venetoclax combination is a common treatment, and we want to see if the new sonrotoclax combination is more effective at keeping the disease from getting worse. About 652 people worldwide will join, and everyone has an equal chance of receiving either treatment.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

BeOne Medicines

Enrolment target

652

Start

11 Nov 2023

Estimated completion

01 Dec 2032

CLL

What is this study about?

Chronic lymphocytic leukaemia (CLL) is a type of blood cancer that affects many people. It can cause problems like swollen glands, spleen, or liver, and symptoms such as drenching night sweats, unexpected weight loss, and fevers. People with CLL often have a shorter life expectancy. This means it's really important to find new and more effective treatments that can help people live longer and manage their symptoms better.

This particular study is looking at two different treatment combinations for CLL. One combination, venetoclax plus obinutuzumab, is already a standard treatment for people who are just starting their CLL journey. The other combination, sonrotoclax plus zanubrutinib, is a newer approach that researchers hope might be even better.

The main goal of this study is to see which combination keeps the CLL from getting worse for a longer period of time. Researchers believe that the sonrotoclax and zanubrutinib combination might be more effective than the standard treatment. Around 652 people from different parts of the world will take part, and each person will have an equal chance of receiving either treatment combination. This helps ensure the study results are fair and reliable.

Key takeaways

This study compares two treatments for untreated CLL.
It aims to find out if a new drug combination is more effective.
Participation involves receiving one of two treatment combinations and regular check-ups.
About 652 people globally will join this research.
Your health will be closely monitored throughout the study.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with chronic lymphocytic leukaemia (CLL) and need to start treatment. You must not have received any previous treatment for your CLL. Your general health should be good enough to participate, as assessed by a doctor, and your liver and kidney functions need to be working well.

There are also some reasons why you might not be able to join. For example, if you've had previous treatment for CLL, or if your CLL has changed into a more aggressive type of cancer called Richter's transformation. You also can't have certain other health conditions like uncontrolled high blood pressure or a specific brain infection called progressive multifocal leukoencephalopathy (PML).

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 or older?
Have you been diagnosed with CLL?
Have you never received treatment for your CLL?
Are you generally well enough for a clinical study?
Do you have good liver and kidney function?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of two treatment groups by chance, like flipping a coin. You will receive either the sonrotoclax and zanubrutinib combination or the venetoclax and obinutuzumab combination. You will have regular visits to the clinic for assessments, which will likely include blood tests, physical examinations, and scans to check your CLL.

The medications will be provided as part of the study. You will receive your assigned treatment for a specific period, and doctors will carefully monitor how you are responding and if you experience any side effects. Even after your treatment period, there will be follow-up appointments to track your health and the progress of your CLL. The total duration of your participation, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as access to a new treatment combination that might be more effective than current options for CLL. However, like all medications, there are potential risks, including side effects from the treatments. The study doctors and nurses will closely monitor you for any side effects and manage them as best as possible. You are absolutely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (201)

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

Alaska Oncology and Hematology, Llc
Verified postcode
Anchorage, United States
City of Hope National Medical Center
Verified postcode
Duarte, United States
University of California San Diego (Ucsd) Moores Cancer Center
Verified postcode
La Jolla, United States
Valkyrie Clinical Trials
Verified postcode
Los Angeles, United States
UCLA Department of Medicine Hematologyoncology
Verified postcode
Los Angeles, United States
Chao Family Comprehensive Cancer Center
Verified postcode
Orange, United States
Stanford Medicine
Verified postcode
Palo Alto, United States
University of Colorado Cancer Center
Verified postcode
Aurora, United States
Medstar Georgetown University Hospital
Verified postcode
Washington D.C., United States
Mount Sinai Medical Center Braman Comprehensive Cancer Center
Verified postcode
Miami, United States
Moffitt Cancer Center
Verified postcode
Tampa, United States
Southeastern Regional Medical Center
Verified postcode
Newnan, United States

Common questions

What is CLL?

CLL stands for chronic lymphocytic leukaemia, which is a type of slow-growing blood cancer that affects white blood cells.

What's the main goal of this trial?

The main goal is to see if a newer drug combination helps people with CLL live longer without their cancer getting worse, compared to a standard treatment.

Will I get to choose my treatment?

No, you won't choose your treatment group. You'll be assigned to one of the two combinations by chance, to ensure the study is fair.

How many people are in this study?

Around 652 people worldwide will be taking part in this study.

What does 'treatment-naïve' mean?

It means you have never had any treatment for your CLL before.

How to find out more

Official trial record

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