Phase 2 Leukaemia Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have signed the official consent form for this study
• People who have a confirmed diagnosis of chronic lymphocytic leukaemia (CLL), including less common forms with slightly different cell markers
• People who have previously been treated with a cancer medication called zanubrutinib as their most recent treatment, and who received at least one full 28-day course of it
• People whose doctor believes they need a second or later round of treatment for their CLL, based on recognised medical guidelines
• People who are 18 years of age or older at the time of signing the consent form
• People who are reasonably active and able to care for themselves (a physical fitness rating of 0 to 2 on a standard medical scale)
• People whose bone marrow is producing enough blood cells — specifically, a certain minimum level of white blood cells, platelets, and haemoglobin — without having had a blood transfusion in the 7 days before testing (though a medication to boost white blood cell production may be allowed if the bone marrow is affected by CLL)
• People whose liver is working well enough, based on blood test results within accepted ranges
• People whose kidneys are working well enough, measured by how well they filter waste from the blood
• People who are able to swallow tablets
• People who have waited at least 24 hours after their last dose of zanubrutinib before starting the new study drug
• People whose side effects from previous cancer treatment have mostly resolved, except for hair loss or mild nerve-related symptoms
• Women who could become pregnant who have had a negative blood pregnancy test within 14 days before starting the study drug
• Men whose partners could become pregnant, and women who could become pregnant, who agree to use a reliable form of contraception during the study and for at least 6 months after the last dose of the study drug — and who agree not to donate sperm during the study or for 6 months after the last dose (confirm with trial site for the full list of accepted contraception methods)
• People who understand the purpose of the trial and are willing to follow all the required procedures

Who may not be able to join:

• People who have had, or are suspected to have had, their CLL transform into a more aggressive type of lymphoma or leukaemia
• People who have had, or are suspected to have had, their cancer spread to the brain or spinal cord
• People who have had a stem cell transplant or a CAR-T cell therapy in the past 60 days, or who still have complications from those treatments such as graft-versus-host disease, ongoing immune suppression, or certain nerve-related side effects
• People who test positive for HIV
• People currently receiving other cancer treatments at the same time
• People who have taken high-dose steroid medications (such as prednisone at 20 mg or more per day) within 7 days before the planned start date, or any dose of steroids taken specifically to treat cancer
• People who have received a live vaccine within 28 days before joining the study
• People whose heart's electrical activity shows a specific type of prolonged interval on a heart tracing (ECG), beyond the level considered safe for this study (confirm with trial site)
• Women who are currently pregnant or plan to become pregnant within one month after the last dose of the study drug
• Women who are currently breastfeeding or plan to breastfeed during the study or within one week after the last dose
• People who currently have another active cancer
• People who have a condition that significantly affects how the gut absorbs medications, such as having had part of the small intestine removed
• People with active hepatitis B or C infection, depending on specific blood test results (confirm with trial site for details)
• People with a known active cytomegalovirus (CMV) infection
• People with other significant uncontrolled medical conditions that the trial doctor believes would make participation unsafe
• People with an active, uncontrolled immune condition causing the body to attack its own blood cells, where new or increased medication was needed in the 4 weeks before joining — though stable, well-controlled cases may still be considered
• People who have previously been treated with the study drug, pirtobrutinib
• People currently taking blood-thinning medications called warfarin or other vitamin K antagonists
• People with a known allergic reaction to any ingredient in pirtobrutinib
• People with significant heart conditions, including recent chest pain episodes, a recent heart attack, poor heart pumping function, severe heart failure, or uncontrolled irregular heart rhythms
• People who have had serious or uncontrolled irregular heart rhythms, including severe episodes while on a previous BTK inhibitor medication
• People who have had a major bleeding episode while taking a previous BTK inhibitor medication
• People who have had a stroke or bleeding in the brain within the past 6 months
• People who have had major surgery within the past 4 weeks
• People with a history of a condition that makes them bleed more easily than normal
• People currently taking certain medications that strongly affect how the body processes the study drug (known as strong P-gp inhibitors — confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.