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RecruitingPHASE3INTERVENTIONAL

A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors

This research study is testing a new medicine called BGB-16673 for a type of blood cancer called chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). We are looking for people whose cancer has already been treated with two different kinds of drugs (BTK and BCL2 inhibitors) but has either come back or gotten worse. The main goal is to see if BGB-16673 can keep the cancer from getting worse for longer, compared to current standard treatments. About 250 people worldwide will take part, being randomly assigned to receive either the new drug or one of the standard treatments chosen by their doctor. Your doctor can help you understand if this study might be right for you.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
BeOne Medicines
Enrolment target
250
Start
10 Apr 2025
Estimated completion
14 Feb 2030

What is this study about?

This study is for people who have a type of blood cancer called chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). These conditions affect your white blood cells and can cause swollen lymph nodes, spleen, or liver, along with other symptoms like night sweats, weight loss, or fever. Unfortunately, people with CLL or SLL may have a shorter life expectancy, so there's a real need to find new and better treatments.

In this study, we are focusing on patients whose CLL or SLL has returned or worsened after they've already tried two specific types of medicines: BTK inhibitors and BCL2 inhibitors. This means your cancer has been quite stubborn. We want to see if a new experimental drug, BGB-16673, can be an effective option for you when other treatments haven't worked as well as hoped.

Researchers will compare BGB-16673 to some existing treatments that doctors might choose, such as a combination of idelalisib and rituximab, or bendamustine and rituximab, or even a different course of venetoclax and rituximab. The main thing we'll be looking at is how long patients live without their cancer getting worse. Around 250 people from different parts of the world will join, and they will be randomly put into groups to receive either BGB-16673 or one of the chosen standard treatments. This helps ensure the study is fair and gives reliable results.

Key takeaways

  • This study is for people with advanced CLL or SLL that has relapsed after specific prior treatments.
  • It compares a new drug (BGB-16673) with existing standard treatments.
  • Participation involves being randomly assigned to a treatment group.
  • Regular clinic visits, blood tests, and scans will monitor your health.
  • The main aim is to see which treatment keeps the cancer under control for longer.

Who may be eligible?

To join this study, doctors will first check if you have a confirmed diagnosis of CLL or SLL and if your condition requires treatment. It's important that you have already received treatment for your CLL or SLL using specific medicines known as BTK inhibitors and BCL2 inhibitors. If you have SLL, your doctors need to be able to see and measure your cancer using scans like CT or MRI.

Other important checks include your general health and how well your body is working. Your doctor will assess your overall physical condition, and they'll also check your liver and blood clotting functions to make sure they are healthy enough to take part in the study. You must be at least 18 years old.

However, there are reasons why you might not be able to join. For example, if you have another more aggressive type of leukemia or if your cancer has spread to your brain or spinal cord. Also, if you've recently had certain types of transplants or cell therapy, or if you have a serious infection, or certain heart problems, you might not be eligible. Your study doctor will review all these details carefully with you.

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.

  1. Do you have a confirmed diagnosis of CLL or SLL which needs treatment?
  2. Have you already been treated with both a BTK inhibitor and a BCL2 inhibitor?
  3. Is your overall health suitable, with good liver and blood clotting function?
  4. Are you at least 18 years old?
  5. Do you not have an aggressive type of leukemia or certain serious heart conditions?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly assigned to receive either the new drug, BGB-16673, or one of several existing treatments. Neither you nor your doctor will get to choose which treatment you receive; this is done by chance, like flipping a coin, to make the study fair. The treatments will be given according to a set schedule, which might involve taking medicine by mouth or through an infusion (drip).

Throughout the study, you will have regular visits to the clinic. These visits will involve various tests, such as blood tests, physical examinations, and scans (like CT or MRI) to monitor your health and how your cancer is responding to the treatment. These checks are important for your safety and to see if the treatment is working. The study team will explain how often these visits will be and what they will involve.

The duration of your participation will depend on how you respond to the treatment. You will continue treatment as long as it is helping you and you are not experiencing severe side effects. Even after you stop receiving the study drug, there will be follow-up appointments to continue monitoring your health. The total duration of your involvement could be several years, including follow-up.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to a new experimental treatment, BGB-16673, which could be more effective for your cancer, especially if other treatments haven't worked well. However, like all medicines, BGB-16673 and the standard treatments have potential risks and side effects, some of which could be serious. The study team will explain these risks in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (117)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • St Bernards Medical Center
    Verified postcode
    Jonesboro, United States· Recruiting
  • UCLA Department of Medicine Hematologyoncology
    Verified postcode
    Los Angeles, United States· Recruiting
  • Pih Health Whittier Hospital
    Verified postcode
    Whittier, United States· Recruiting
  • Rocky Mountain Cancer Centers (Williams) Usor
    Verified postcode
    Aurora, United States· Recruiting
  • Florida Oncology and Hematology
    Verified postcode
    Fort Myers, United States· Recruiting
  • Baptist Md Anderson Cancer Center
    Verified postcode
    Jacksonville, United States· Recruiting
  • Cleveland Clinic Florida
    Verified postcode
    Weston, United States· Recruiting
  • Emory University Winship Cancer Institute
    Verified postcode
    Atlanta, United States· Recruiting
  • Northside Cancer Center
    Verified postcode
    Atlanta, United States· Recruiting
  • Our Lady of the Lake Hospital
    Verified postcode
    Baton Rouge, United States· Recruiting
  • American Oncology Partners of Maryland Pa
    Verified postcode
    Bethesda, United States· Recruiting
  • Oncology Hematology Associates
    Verified postcode
    Springfield, United States· Recruiting

Common questions

What is chronic lymphocytic leukemia (CLL)?

CLL is a type of cancer that affects your white blood cells, which are important for fighting infections. It causes your body to make too many abnormal white blood cells.

What does 'previously exposed' to drugs mean?

It means you have already received treatments called BTK inhibitors and BCL2 inhibitors for your CLL or SLL, but your cancer has either come back or worsened.

What is BGB-16673?

BGB-16673 is a new experimental drug being tested in this study to see if it can help treat CLL or SLL.

Will I definitely get the new drug?

No, you will be randomly assigned to either receive BGB-16673 or one of the standard existing treatments. It's like flipping a coin.

What is the main goal of the study?

The main goal is to compare how long patients live without their CLL or SLL getting worse when they receive BGB-16673 versus standard treatments.

How to find out more

Study Director

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of BGB-16673 Compared to Investigator's Choice in Pa…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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