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A Study Comparing BGB-16673 to Pirtobrutinib for Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Has Returned or Not Responded

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, which are types of blood cancers that affect white blood cells and can also involve the lymph nodes. These conditions belong to a group of cancers where abnormal white blood cells build up in the blood, bone marrow, and lymph nodes. The study compares two medications: BGB-16673, which is an investigational drug being tested, and pirtobrutinib, which is an approved medication. Both drugs are given as tablets that are taken by mouth. The study focuses on patients whose disease has come back after previous treatment or did not respond to earlier treatment that included a specific type of medication called a covalent Bruton tyrosine kinase inhibitor.

The purpose of the study is to compare how well BGB-16673 works against pirtobrutinib in controlling the disease and to evaluate the safety of both treatments. The study will measure how long patients live without their disease getting worse, which is called progression-free survival. This will be assessed by an independent group of medical experts who will review imaging scans and other test results. The study will also look at overall survival, which means how long patients live overall, and will measure how many patients respond to treatment by having their disease shrink or disappear. Additional measurements include how long the treatment response lasts and how long it takes before patients need another treatment for their disease.

During the study, patients will be randomly assigned to receive either BGB-16673 or pirtobrutinib. Both groups will continue taking their assigned medication for up to 42 months unless their disease gets worse or they experience unacceptable side effects. The study will monitor patients for any unwanted effects of the medications and will track how severe these effects are. Patients will also complete questionnaires about their quality of life, including questions about their physical functioning, symptoms, and overall health status. The study will use computed tomography or magnetic resonance imaging scans to measure disease in patients with small lymphocytic lymphoma, looking for lymph nodes that are larger than normal size.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Random assignment to treatment group

    Upon joining the study, you will be randomly assigned to receive either BGB-16673 or pirtobrutinib. Both medications are taken by mouth in the form of film-coated tablets.

    The random assignment means that neither you nor your doctor can choose which medication you will receive. This is done to ensure the study results are reliable.

  2. Step 2

    Treatment phase

    You will receive one of two medications, depending on your assigned group. Both are designed to treat your condition and are taken orally.

    If assigned to the BGB-16673 group, you will take this medication according to the dosing schedule provided by your study doctor.

    If assigned to the pirtobrutinib group (also known as Jaypirca), you will take 100 mg tablets according to the dosing schedule provided by your study doctor.

    The specific dosage, frequency, and duration of treatment will be determined by your study doctor based on the study protocol and your individual response to the medication.

  3. Step 3

    Regular monitoring and assessments

    Throughout the study, you will undergo regular monitoring to evaluate how the treatment is working and to check for any side effects.

    This will include imaging tests such as computed tomography (a type of scan that creates detailed pictures of the inside of your body) or magnetic resonance imaging (another type of scan that uses magnets and radio waves to create images).

    Your doctor will assess whether your disease is responding to treatment, staying stable, or progressing. This assessment will be done by both your study doctor and an independent group of experts who review the results.

    Blood tests and other laboratory tests will be performed regularly to monitor your overall health and detect any abnormalities.

  4. Step 4

    Quality of life assessments

    You will be asked to complete questionnaires about your overall health, daily activities, physical functioning, and any symptoms you may be experiencing.

    These questionnaires help evaluate how the treatment affects your quality of life, including your energy levels and ability to perform everyday tasks.

  5. Step 5

    Safety monitoring

    Your study doctor will closely monitor you for any side effects or adverse events that may occur during treatment.

    Any side effects will be recorded and graded according to their severity using standardized criteria.

    If you experience any side effects, your doctor may adjust your treatment or provide additional care as needed.

  6. Step 6

    Continuation of treatment

    You will continue taking your assigned medication as long as it is benefiting you and you are not experiencing unacceptable side effects.

    Your doctor will regularly evaluate whether the disease is responding to treatment or if it is progressing.

    The duration of your participation in the study will depend on how well the treatment works for you and how well you tolerate it.

  7. Step 7

    End of treatment and follow-up

    If you stop taking the study medication for any reason, you will enter a follow-up period.

    During follow-up, your doctor will continue to monitor your health status and disease progression.

    Information will be collected about any additional treatments you may receive for your condition after stopping the study medication.

    The study is expected to continue until approximately November 2028, though your individual participation may be shorter or longer depending on your specific circumstances.

Who can join the trial?

6 criteria

  • You must have a confirmed diagnosis of chronic lymphocytic leukemia, which is a type of cancer affecting white blood cells in the blood and bone marrow, or small lymphocytic lymphoma, which is a similar cancer mainly affecting the lymph nodes, and your disease must need treatment based on medical guidelines from 2018
  • You must have received treatment before for your disease with a specific type of medicine called a covalent Bruton tyrosine kinase inhibitor, which is a drug that blocks a protein involved in cancer cell growth
  • Your disease must have come back after treatment or did not respond to at least one previous treatment that included a covalent Bruton tyrosine kinase inhibitor
  • If you have small lymphocytic lymphoma, you must have disease that can be measured using imaging scans such as computed tomography, which is a special x-ray that creates detailed pictures of the inside of your body, or magnetic resonance imaging, which uses magnets and radio waves to create images of your body, and you must have at least one swollen lymph node that is larger than 1.5 centimeters in its longest measurement and can be measured in two different directions
  • You can be male or female
  • You must be an adult aged 18 years or older

Who cannot join the trial?

1 criterion

  • The exclusion criteria information is not available in the provided study data
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Investigated drugs

  • BGB-16673

    is an investigational medication being studied in this trial. It is being tested to see how well it works and how safe it is for people with chronic lymphocytic leukemia or small lymphocytic lymphoma that has come back or has not responded to previous treatments.

  • Pirtobrutinib

    is a medication used to treat certain types of blood cancers. In this trial, it is being used as a comparison treatment to see how well the new medication BGB-16673 works in comparison.

What is already known about the treatment

  • BGB-16673

    BGB-16673 is an investigational medication currently being studied in clinical trials for the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma that has returned or not responded to previous treatments. This drug is being tested in tablet or capsule form taken by mouth, and it works by blocking specific proteins inside cancer cells that help them grow and survive. It belongs to a class of medicines called targeted therapy agents, which are designed to interfere with specific molecules involved in cancer cell growth. The medication is being compared to another similar drug called pirtobrutinib to determine if it can better slow down or stop the progression of these blood cancers.

  • Pirtobrutinib

    Pirtobrutinib is a targeted cancer medication taken orally in tablet form that is used to treat chronic lymphocytic leukemia and small lymphocytic lymphoma when the disease has come back or has not responded to other treatments. It works by blocking a protein called BTK (Bruton's tyrosine kinase) that cancer cells need to grow and multiply, thereby helping to slow or stop the spread of cancer. This drug belongs to a class of medications known as BTK inhibitors, which specifically target this protein pathway in cancerous white blood cells. Pirtobrutinib is approved for use in certain patients and is being used as a comparison treatment in clinical trials to evaluate newer medications for these blood cancers.

Investigated diseases

  • Chronic Lymphocytic Leukemia

    Chronic lymphocytic leukemia is a type of cancer that affects the blood and bone marrow. It occurs when the body produces too many abnormal white blood cells called lymphocytes. These abnormal cells gradually accumulate in the blood, bone marrow, and lymph nodes over time. The disease typically progresses slowly, which is why it is called chronic. As the condition advances, the abnormal cells can crowd out healthy blood cells, leading to reduced production of normal blood cells. The buildup of these cells can cause enlargement of lymph nodes and the spleen.

  • Small Lymphocytic Lymphoma

    Small lymphocytic lymphoma is a type of cancer that affects the lymphatic system, which is part of the body's immune system. It involves the abnormal growth of small white blood cells called lymphocytes in the lymph nodes and other lymphoid tissues. The disease is closely related to chronic lymphocytic leukemia and progresses slowly over time. As the condition develops, the abnormal lymphocytes accumulate in the lymph nodes, causing them to enlarge. The cancerous cells can also spread to other parts of the lymphatic system, including the spleen and bone marrow. This gradual buildup of abnormal cells interferes with the normal function of the immune system.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522860-34-00Protocol codeBGB-16673-304Estimated enrolment521 patientsSponsorBeOne Medicines AG

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