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A Study Comparing DZD8586 to Other Treatments for Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Has Returned or Not Responded

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is studying relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma, which are types of blood cancers that affect white blood cells called lymphocytes. Relapsed means the cancer has come back after treatment, while refractory means the cancer did not respond well to previous treatment. The study will compare the effectiveness of an investigational medicine called DZD8586 (also known as birelentinib) with treatments chosen by the doctor. The doctor's choice of treatment may include idelalisib taken by mouth, or a combination of bendamustine hydrochloride given through a vein and rituximab given through a vein. The purpose of this study is to evaluate whether DZD8586 works better than the doctor's choice of treatment in controlling the cancer.

Participants in this study must have received previous treatment with medicines called BTK inhibitors that either did not work, stopped working, or caused side effects that could not be tolerated. They should also have been previously treated with a type of medicine called BCL-2 inhibitors according to local medical practice. The study will randomly assign patients to receive either DZD8586 or one of the doctor's choice treatments. DZD8586 is given as a tablet taken by mouth daily for up to 36 months. If the doctor chooses idelalisib, it is also taken by mouth daily for up to 36 months. If the doctor chooses the combination treatment, bendamustine is given through a vein and rituximab is given through a vein for up to 24 weeks.

During the study, doctors will monitor how well the treatment controls the cancer by checking for signs of disease progression and measuring how long patients remain free from cancer growth. They will also assess overall survival, quality of life, and safety by monitoring for any side effects or health problems that may occur during treatment. Blood samples will be collected to measure the levels of DZD8586 in the body to understand how the medicine is processed.

The research process

The trial runs in 11 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment assignment

    Upon joining the study, you will be assigned to one of two treatment groups. The assignment will be done randomly, similar to flipping a coin.

    One group will receive DZD8586, and the other group will receive a treatment chosen by your doctor from available options.

  2. Step 2

    Treatment with DZD8586 or doctor's choice

    If you are assigned to receive DZD8586, you will take this medication by mouth in the form of a film-coated tablet. The specific dosage, frequency, and duration of treatment will be determined by your doctor based on the study protocol.

    If you are assigned to the other group, your doctor will choose from available treatment options. These may include:

    Idelalisib: taken by mouth as a film-coated tablet. Available in 100 mg or 150 mg doses.

    Bendamustine hydrochloride: given through a vein as an intravenous infusion.

    Rituximab: given through a vein as a solution for infusion, available in 500 mg doses.

    The combination may include bendamustine and rituximab together, or idelalisib and rituximab together, depending on your doctor's decision and your medical condition.

    The specific dosage, frequency, and duration of these medications will be determined by your doctor according to standard treatment practices and the study requirements.

  3. Step 3

    Regular monitoring visits

    Throughout the study, you will attend regular visits at the study site. During these visits, your doctor will monitor your condition and the effects of the treatment.

    Blood samples will be collected to check your blood cell counts, liver function, kidney function, and other laboratory values.

    Your heart function will be assessed using echocardiography, a test that uses sound waves to create images of your heart.

    Physical examinations will be performed to check for any changes in the size of your lymph nodes, spleen, or other organs affected by the disease.

    Imaging tests may be performed to measure the size of any enlarged lymph nodes or other affected areas. For those with small lymphocytic lymphoma, at least one measurable area larger than 1.5 cm in lymph nodes or larger than 1.0 cm outside lymph nodes should be present.

  4. Step 4

    Safety assessments

    Your doctor will regularly assess any side effects or unwanted reactions you may experience during the study. These are called adverse events.

    If you experience any symptoms or health changes, you should report them to your doctor immediately, even if they seem minor.

    Blood tests will be performed regularly to monitor for any effects on your blood cells, liver, or kidneys. These include checking your absolute neutrophil count (a type of white blood cell), platelet count (cells that help blood clot), and blood clotting times.

    Your doctor will also monitor specific blood tests including activated partial thromboplastin time, prothrombin time, and international normalized ratio, which measure how well your blood clots.

    Tests will check your total bilirubin (a substance produced by the liver), alanine aminotransferase, and aspartate aminotransferase (enzymes that indicate liver function).

    Your kidney function will be monitored by measuring creatinine clearance, which shows how well your kidneys are filtering waste from your blood.

  5. Step 5

    Quality of life assessments

    You will be asked to complete questionnaires about your quality of life and how you are feeling during the study.

    These questionnaires include the EQ-5D-5L, which asks about your mobility, self-care, usual activities, pain, and anxiety or depression.

    You will also complete the EORTC QLQ-C30, which asks specific questions about symptoms and quality of life related to cancer and its treatment.

  6. Step 6

    Response evaluation

    Your doctor will regularly evaluate how well the treatment is working by assessing whether your disease is responding to treatment.

    This evaluation will include physical examinations, blood tests, and imaging studies to measure changes in the size of lymph nodes and other affected areas.

    The response will be assessed according to established guidelines for chronic lymphocytic leukemia and small lymphocytic lymphoma.

    An independent group of doctors not directly involved in your care will also review your test results to provide an additional evaluation of how the treatment is working.

  7. Step 7

    Blood sample collection for drug levels

    If you are receiving DZD8586, blood samples will be collected at specific times to measure the amount of the drug and its breakdown product DZ4581 in your blood.

    These measurements help doctors understand how the drug is processed by your body.

  8. Step 8

    Continuing treatment

    You will continue receiving the assigned treatment until your disease progresses, you experience unacceptable side effects, or you decide to withdraw from the study.

    Your doctor will continue to monitor your condition throughout the treatment period.

  9. Step 9

    End of treatment

    When you stop receiving the study treatment, you will have an end-of-treatment visit where final assessments will be performed.

    These assessments will include physical examination, blood tests, and evaluation of any ongoing side effects.

  10. Step 10

    Follow-up period

    After completing treatment, you will enter a follow-up period where your doctor will continue to monitor your health and disease status.

    The follow-up period will continue until the end of the study, which is estimated to be in November 2028.

    During follow-up, your doctor will track important outcomes such as how long you remain free from disease progression, your overall survival, and when you may need to start a new treatment for your condition.

  11. Step 11

    Contraception requirements

    If you are a woman of childbearing potential, you must use effective birth control methods during the study and for a period after your last dose of study medication.

    You must continue using birth control for 3 months after the last dose of DZD8586 or idelalisib, 6 months after the last dose of bendamustine, and 12 months after the last dose of rituximab, whichever is longer.

    Acceptable birth control methods include sexual abstinence, tubal ligation, hormonal contraception with low risk of drug interactions such as the levonorgestrel intrauterine system or medroxyprogesterone injection, copper intrauterine devices, or having a partner who has had a vasectomy.

    All hormonal birth control methods except abstinence should be used together with condoms used by your male partner.

    You must not breastfeed during the study.

    You will have a pregnancy test before starting the study treatment to confirm you are not pregnant.

    If you are a male participant with a female partner of childbearing potential, you must use barrier contraception such as condoms during the study and for 6 months after the last dose of DZD8586, bendamustine, or idelalisib, or 12 months after the last dose of rituximab, whichever is longer.

    You should not donate sperm during this same time period.

    If you wish to father children in the future, you should consider freezing sperm samples before starting the study treatment.

Who can join the trial?

1 criterion

  • You must sign a consent form before any study procedures begin. If you are a woman who can become pregnant, you must use reliable birth control methods during the study and for up to 12 months after your last dose of study medicine, whichever is longer. Birth control methods include not having sex, having your tubes tied, using certain hormonal methods like the Mirena device (a small device placed in the uterus that releases hormones) or Depo Provera injection (a shot that prevents pregnancy), using a copper device placed in the uterus, or your male partner having had a vasectomy (a procedure to prevent pregnancy). If using hormonal birth control, your male partner must also use condoms. You must not breastfeed during the study. You must have a negative pregnancy test before starting treatment. You may join the study if you are past menopause, meaning you are over 50 years old and have not had a period for at least 12 months after stopping hormone treatments, or if you are under 50 years old and have not had a period for 12 months with certain hormone levels in the normal range for menopause. You may also join if you have had surgery to remove your uterus, both ovaries, or both fallopian tubes. You must be 18 years old or older when signing the consent form. Your general health and ability to care for yourself must be rated as 0, 1, or 2 on a scale called ECOG performance status, which measures how well you can perform daily activities. Your health should not have gotten worse in the past 2 weeks. You must have a diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma, which are types of blood cancer. Your disease must have come back, not responded to treatment, or caused intolerable side effects during or after previous treatment with a BTK inhibitor, which is a type of cancer medicine. The disease is considered not responding to treatment if it gets worse during treatment or within 6 months after it improved. The disease has relapsed if it comes back after at least 6 months of having a partial or better response. Your disease is considered not responding to BTK inhibitor if it stays stable after 6 months of standard treatment, or if it gets worse after at least 8 weeks of treatment, or if it progresses after responding for at least 6 months. You may join if you stopped BTK inhibitor due to side effects such as the same moderate or worse non-blood-related side effect lasting 7 days or more and happening twice or more, the same severe non-blood-related side effect lasting 7 days or more or happening twice or more, very severe non-blood-related side effects, the same severe blood-related side effect lasting 7 days or more and happening twice or more, severe low white blood cell count with infection or fever, severe low platelet count with significant bleeding, very severe blood-related side effects lasting 7 days or more or happening twice or more, or moderate or higher side effects that your doctor judged as high risk. You must have been previously treated with a BCL-2 inhibitor, which is another type of cancer medicine, according to local practice in European countries. Your expected survival must be at least 3 months. Your doctor must determine that you need treatment based on specific criteria, including disease remaining after initial treatment, worsening of anemia (low red blood cells) or thrombocytopenia (low platelets), enlarged spleen measuring 6 centimeters or more below the left rib or growing or causing symptoms, large lymph nodes measuring 10 centimeters or more or growing or causing symptoms, rapidly increasing white blood cell count rising 50 percent or more over 2 months or doubling in less than 6 months, cancer spread to organs like skin, kidney, lung, or spine causing symptoms, immune-related anemia or thrombocytopenia not responding well to steroids, or disease-related symptoms such as unintentional weight loss of 10 percent or more in 6 months, significant tiredness preventing usual activities, fevers of 100.5 degrees Fahrenheit or 38 degrees Celsius for 2 weeks or more without infection, or night sweats for 1 month or more without infection. If you have small lymphocytic lymphoma, you must have at least one measurable tumor, meaning a lymph node larger than 1.5 centimeters or a tumor outside lymph nodes larger than 1.0 centimeters. Your bone marrow and organs must function adequately. You must not have received blood transfusions or growth factors in the 7 days before joining. Your absolute neutrophil count (a type of white blood cell) must be at least 0.75 multiplied by 10 to the power of 9 per liter. Your platelet count (cells that help blood clot) must be at least 50 multiplied by 10 to the power of 9 per liter, or at least 75 if you will receive bendamustine and rituximab treatment. Your blood clotting times must be no more than 1.5 times the upper normal limit. Your total bilirubin (a substance from broken down red blood cells) must be no more than 1.5 times the upper normal limit, or no more than 3 times if you have Gilbert's Syndrome (a harmless liver condition) or cancer in your liver. Your liver enzymes called ALT and AST must be no more than 2.5 times the upper normal limit, or no more than 3 times if you have cancer in your liver. Your creatinine clearance (a measure of kidney function) must be at least 30 milliliters per minute. Your left ventricular ejection fraction (a measure of how well your heart pumps blood) must be at least 50 percent as measured by echocardiography, which is an ultrasound test of your heart. You must be able to follow study requirements for taking the study medicine and attending follow-up visits. If you are a man whose female partner can become pregnant, you must use barrier contraception like condoms during the study and for up to 12 months after your last dose of study medicine, whichever is longer. You must also avoid donating sperm during the study and for up to 12 months after your last dose, whichever is longer. If you wish to father children, you should consider freezing sperm samples before starting treatment.

Who cannot join the trial?

4 criteria

  • The study does not list specific reasons why patients cannot participate in this trial based on the available information.
  • If you are considering joining this study, the research team will review your complete medical history and current health condition to determine if you are eligible.
  • General factors that might prevent participation could include other serious health conditions, certain medications you are taking, or previous treatments you have received.
  • Your doctor will need to evaluate whether this study is appropriate for your individual situation.
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Investigated drugs

  • DZD8586

    is an investigational medication being tested in this clinical trial for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that has come back or has not responded to previous treatments. This medication is being studied to see how well it works at fighting cancer cells compared to other standard treatment options chosen by the doctor.

  • Investigator's Choice

    refers to standard treatment medications that the doctor selects based on what is typically used for this type of cancer. These are approved medications that doctors commonly prescribe for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma when the disease returns or does not respond to initial treatment. The specific medication chosen will depend on the individual patient's condition and treatment history.

What is already known about the treatment

DZD8586 – DZD8586 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 a Phase 3 study to compare its effectiveness against standard treatment options chosen by doctors. The exact way DZD8586 works in the body and its specific form of administration have not been publicly disclosed at this stage of clinical development, as it remains an experimental therapy undergoing evaluation to determine if it can provide better outcomes for patients with these types of blood cancers.

Investigated diseases

  • Chronic Lymphocytic Leukemia

    Chronic Lymphocytic Leukemia is a type of cancer that affects the blood and bone marrow, where too many abnormal white blood cells called lymphocytes are produced. These abnormal cells build up slowly over time in the blood, bone marrow, and lymph nodes. The disease typically progresses gradually, and many people may not have symptoms in the early stages. As the condition advances, the abnormal cells crowd out healthy blood cells, which can lead to problems with fighting infections, bleeding, and fatigue. The term "relapsed" means the disease has returned after treatment, while "refractory" indicates it has not responded to previous treatments. This is a chronic condition that develops over months to years rather than quickly.

  • Small Lymphocytic Lymphoma

    Small Lymphocytic Lymphoma is a slow-growing cancer of the lymphatic system, which is part of the body's immune system. In this condition, abnormal small lymphocytes accumulate primarily in the lymph nodes, spleen, and other lymphatic tissues. The disease is closely related to Chronic Lymphocytic Leukemia and shares many similar features, with the main difference being where the abnormal cells are found. The lymphoma progresses slowly, and affected lymph nodes may gradually enlarge over time. People with this condition may experience swollen lymph nodes, fatigue, and increased susceptibility to infections as the disease advances. Like Chronic Lymphocytic Leukemia, it can relapse after treatment or be refractory to standard therapies.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522669-32-00Protocol codeDZ2024B0002Estimated enrolment250 patientsSponsorDizal Pharmaceutical Co. Ltd.

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