Phase 2 Lymphoma 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 been diagnosed with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) according to standard 2018 medical guidelines
• People whose CLL can be detected through a blood or bone marrow test called flow cytometry at the time of joining the trial
• People aged 18 years or older
• People who are reasonably well and able to care for themselves, based on a standard medical scoring system (rated 0–2 on a scale that measures general health and ability to do daily activities)
• People who are currently taking one of three specific cancer medicines — ibrutinib, acalabrutinib, or zanubrutinib — at any dose, and have been tolerating it for more than 4 weeks
• People whose CLL is getting worse despite being on one of those medicines, as shown by standard medical measures of disease progression or a rapid rise in a specific type of white blood cell
• People whose liver function blood test results are within acceptable ranges (or slightly higher if the liver is affected by the disease)
• People whose bilirubin (a substance measured in blood) is within acceptable ranges (or slightly higher if the liver is affected by the disease or a condition called Gilbert's disease)
• People whose kidneys are working well enough, based on a standard calculation of kidney filtering ability (a score of at least 30)
• People whose levels of infection-fighting white blood cells (neutrophils) meet a minimum threshold, without needing a blood transfusion or growth factor medicine in the 7 days before screening (though lower levels may be acceptable if the disease is affecting the bone marrow)
• People whose haemoglobin (a measure of red blood cells) meets a minimum level, without needing a transfusion or growth factor medicine in the 7 days before screening (though lower levels may be acceptable if the disease is affecting the bone marrow)
• People whose platelet levels (cells that help blood clot) meet a minimum threshold, without needing a transfusion or growth factor medicine in the 7 days before screening (though lower levels may be acceptable if the disease is affecting the bone marrow)
• People whose blood clotting test results are within acceptable ranges
• People who do not have a known inherited condition that causes platelets to not work properly
• People who are willing and able to complete all trial activities and treatment
• People who are willing to give signed informed consent and follow all trial requirements
• People of reproductive potential, and their partners, who are willing to use reliable contraception throughout treatment and for 6 months after the last dose of pirtobrutinib, or 30 days after the last dose of venetoclax
• For people being considered for re-treatment with pirtobrutinib: people who stopped their initial trial treatment no more than 12 months ago and whose disease is progressing again according to standard medical criteria
• For people being considered for re-treatment with pirtobrutinib: people who have not developed any new health conditions that would make re-treatment unsafe

Who may not be able to join:

• People who are unable to drink or receive through a drip at least 2 litres of fluid
• People who have previously taken venetoclax for more than 13 months, or who are known to not respond to venetoclax
• People who have had an allergic reaction to any ingredient in pirtobrutinib or venetoclax
• People who need to take warfarin or similar blood-thinning medicines during the trial
• People who have a history of a bleeding disorder
• People who experienced a serious bleeding event or a severe heart rhythm problem while previously taking a BTK inhibitor medicine (such as ibrutinib, acalabrutinib, or zanubrutinib)
• People who have had a stroke or bleeding in the brain within the past 6 months
• People who are unable to swallow pills or take medicines by mouth
• People who have a significant condition affecting how the gut absorbs medicine
• People whose CLL or SLL is currently affecting the central nervous system (brain and spinal cord), although exceptions may be considered in certain circumstances by the trial doctor (confirm with trial site)
• People who have recently received other cancer treatments such as targeted therapy, experimental medicines, certain antibody treatments, chemotherapy, or radiation therapy within specified timeframes (note: continuing on ibrutinib, acalabrutinib, or zanubrutinib is allowed)
• People who still have unresolved side effects from a previous treatment that are rated above a mild level (except for hair loss or moderate nerve-related symptoms)
• People who have had a stem cell transplant or CAR-T cell therapy within the past 60 days, or who have ongoing complications from those treatments such as graft-versus-host disease, incomplete blood count recovery, or ongoing immune-suppressing treatment
• People with an active second cancer, unless it is in remission and life expectancy is greater than 2 years (some exceptions apply, such as certain skin cancers and hormone therapies for breast or prostate cancer)
• People with a mental health condition or personal circumstances that may make it difficult to follow the trial requirements
• People with an active, uncontrolled immune condition causing the body to attack its own blood cells, where new or increased treatment was needed in the 4 weeks before joining
• People with other serious uncontrolled health conditions, including active serious infections (other than fungal nail infections)
• People with significant heart problems, including recent unstable chest pain, recent heart attack, poor heart pumping function, severe heart failure, or uncontrolled heart rhythm problems
• People with an abnormal heart electrical reading (a measurement called QTcF greater than 470 milliseconds), unless correctable under medical supervision (people with pacemakers may still be eligible if they have no history of fainting or relevant heart rhythm problems)
• People with active hepatitis B virus infection (specific blood test results determine this), or active hepatitis C virus infection (specific blood test results determine this)
• People known to have HIV, or people whose HIV status is unknown and who test positive at screening
• People with a known active cytomegalovirus (CMV) infection
• People currently taking, or who have recently taken, certain medicines that strongly affect how the body processes other drugs (specific enzyme inhibitors or inducers), or who plan to consume grapefruit, Seville oranges, or star fruit during the trial
• People who are pregnant, breastfeeding, or planning to breastfeed during the trial or within 6 months of the last dose of either study medicine
• People who have had major surgery within 4 weeks before screening
• People who have received a live vaccine within 28 days of screening
• People who are currently incarcerated
• People with a history of a rare brain condition called progressive multifocal leukoencephalopathy (PML) or JC virus infection
• People with a history of seizures, unless seizures have been fully controlled for at least one year before screening
• For people being considered for re-treatment with pirtobrutinib: people who have developed new health conditions since their initial treatment that would make re-treatment unsafe

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