RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

This research study is looking into a new medicine called BGB-16673 and comparing it to pirtobrutinib. Both medicines are for adults who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). These are types of cancer that affect white blood cells. The study is specifically for people whose condition hasn't responded well to a previous treatment called a covalent Bruton tyrosine kinase inhibitor (cBTKi). This study, known as a Phase 3 study, will help doctors understand if BGB-16673 is a safe and effective treatment option for these patients, potentially offering another choice for those needing further treatment.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

BeOne Medicines

Enrolment target

500

Start

04 Sep 2025

Estimated completion

17 Apr 2028

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

What is this study about?

This study is designed for adults living with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). These are cancers that affect a type of white blood cell called lymphocytes. Researchers want to compare a new medicine, BGB-16673, with an existing medicine called pirtobrutinib. The main goal is to find out if BGB-16673 is safer and works better than or as well as pirtobrutinib for people whose CLL or SLL has come back or hasn't responded to a previous treatment.

Taking part in this kind of study is really important because it helps us learn more about new treatments. Finding better ways to manage CLL and SLL can improve the lives of many people. This study focuses on individuals who have already been treated with a specific type of medicine called a covalent Bruton tyrosine kinase inhibitor (cBTKi), but their cancer has either returned or hasn't fully responded.

Our company, BeOne Medicines (you might also see us referred to as BeiGene for older studies), is sponsoring this research. They are committed to finding new and effective treatments, and studies like this are a key step in bringing new medicines to patients who need them.

Key takeaways

This study compares two medicines for CLL or SLL that has returned or not responded to previous therapy.
It's for adults whose cancer has not responded to an earlier cBTKi treatment.
The study aims to see which medicine is safer and works better.
Taking part can help advance our understanding of new cancer treatments.
You'll receive close medical care during the study.
Your right to withdraw from the study at any time is protected.

Who may be eligible?

To join this study, adults must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that needs treatment. It's important that your condition has either returned or not responded well after you've already had a treatment with a specific type of medicine called a covalent Bruton tyrosine kinase inhibitor (cBTKi).

If you have SLL, doctors will need to see that you have at least one enlarged lymph node that can be measured on a scan like a CT or MRI. This helps them track how well the treatment is working. Some conditions would prevent you from joining, such as having a known bleeding problem or a stroke in the last six months. Also, if you’ve had particular other treatments for your cancer, or if your cancer has spread to your brain or spinal cord, you wouldn't be able to take part.

Quick self-check

Do I have a diagnosis of CLL or SLL?
Has my CLL/SLL come back or not responded well to a previous treatment?
Have I been treated before with a covalent Bruton tyrosine kinase inhibitor (cBTKi)?
Do I have any known bleeding problems or a history of stroke in the last six months?
Has my cancer spread to my brain or spinal cord?

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 would receive either BGB-16673 or pirtobrutinib. The medicines will be given in a way that the doctors will explain thoroughly. You will have regular visits to the clinic so the study team can monitor your health, check for any side effects, and see how the treatment is affecting your cancer. These visits will involve various tests, such as blood tests and scans, to keep track of your progress. The study will continue for a period, and you will have follow-up visits even after you stop taking the study medicine. The total duration of your participation will be explained to you in detail by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving close medical attention and potentially benefiting from a new treatment that may help control your chronic lymphocytic leukemia or small lymphocytic lymphoma. However, as with any medical treatment, there are potential risks, including side effects from the study medicines. The medical team will explain all known and potential side effects to you. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (156)

Mayo Clinic Phoenix
Phoenix, United States· Recruiting
Kaiser Permanente Southern California
Irvine, United States· Recruiting
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, United States· Recruiting
Cancer and Blood Specialty Clinic
Los Alamitos, United States· Recruiting
UCLA Department of Medicine Hematologyoncology
Los Angeles, United States· Recruiting
Stanford Cancer Institute
Palo Alto, United States· Recruiting
Christiana Care
Newark, United States· Recruiting
Cancer Specialists of North Florida
Jacksonville, United States· Recruiting
Mayo Clinic Jacksonville
Jacksonville, United States· Recruiting
Mount Sinai Medical Center Braman Comprehensive Cancer Center
Miami, United States· Recruiting
University of Chicago Medical Center
Chicago, United States· Recruiting
The University of Kansas Cancer Center
Westwood, United States· Recruiting

+144 more sites — see the official record for the full list.

Common questions

What's the difference between CLL and SLL?

CLL and SLL are very similar cancers. CLL affects the blood and bone marrow, while SLL mainly affects the lymph nodes. They are often treated in similar ways.

What does 'relapsed/refractory' mean?

This means your cancer has either come back after treatment (relapsed) or it hasn't responded well to previous treatments (refractory).

What is a 'covalent Bruton tyrosine kinase inhibitor (cBTKi)'?

This is a specific type of medicine that targets a protein in cancer cells to stop them from growing. You would have had this type of treatment before considering this study.

Will I know which drug I am receiving?

In some studies, participants know which drug they are getting, while in others, it's decided by chance, and you and your doctor might not know. The study team will explain how this works in this particular trial.

Do I have to pay to be part of the study?

No, you do not have to pay to receive the study medicines or for the specific tests and visits related to the research. Any travel expenses may also be covered, which you can discuss with the study team.

How to find out more

Study Director

clinicaltrials@beonemed.com 1-877-828-5568 Official trial record

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