Early Phase 1 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 are willing to follow all study procedures and take medication by mouth as directed
• People aged 18 years or older
• People who have been diagnosed with Chronic Lymphocytic Leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL) according to established international guidelines
• People whose CLL or SLL is active and has been determined to need treatment according to recognised medical guidelines
• People who have measurable disease, such as enlarged lymph nodes (at least 1.5 cm), an enlarged spleen, a high number of a certain type of white blood cell in the blood, or significant CLL involvement in the bone marrow
• People who have not previously received treatment for CLL, and who have at least one lymph node suitable for a core-needle biopsy (a small tissue sample)
• People who are reasonably well and able to carry out daily activities, as measured by a standard medical scale (ECOG score of 0, 1, or 2)
• People whose liver, kidneys, and blood cell counts are within acceptable ranges as determined by blood tests
• People whose blood clotting test results are within acceptable ranges
• People of childbearing potential, and their partners, who are willing to use highly effective contraception during the study and for one month after the last dose
• People who are able to understand and are willing to sign a written consent form
• People who agree to follow the lifestyle guidelines set out by the study

Who may not be able to join:

• People whose CLL has transformed into a more aggressive cancer called Richter Transformation
• People whose cancer has spread to the central nervous system (brain or spinal cord)
• People who are pregnant, planning to become pregnant during the study, or within one month of the last dose; people of childbearing potential must have a negative pregnancy blood test before joining
• People who are breastfeeding or planning to breastfeed during the study or within one week of the last dose
• People with a known active cytomegalovirus (CMV) infection (a common viral infection)
• People with an active Hepatitis B infection, or those with certain Hepatitis B markers in their blood that indicate active virus (confirm with trial site for specific test results)
• People with an active Hepatitis C infection confirmed by specific blood tests
• People who have HIV with a detectable amount of virus in their blood, or a low immune cell count (CD4 below 350); people with HIV may be considered if they have been stable on HIV treatment for at least four weeks before joining
• People with a condition that significantly affects how the gut absorbs medication, such as having had gastric bypass surgery or surgical removal of the stomach
• People with other serious uncontrolled infections or active medical conditions that the study doctor believes could put them at risk
• People who have had a stroke or bleeding in the brain within the past six months
• People currently experiencing a hypertensive urgency or emergency (a dangerously high blood pressure crisis)
• People with serious active heart conditions, including unstable chest pain or heart attack in the past two to three months, severely reduced heart pumping function, uncontrolled or symptomatic irregular heartbeat, severe heart failure (Class 3 or 4), or an abnormal heart electrical reading (QTcF greater than 470 msec) — people with pacemakers may still be eligible if they have no history of fainting or serious irregular heartbeat
• People with a known allergy or sensitivity to the study drug pirtobrutinib or any of its listed ingredients
• People with a history of a bleeding disorder such as von Willebrand disease or haemophilia
• People who have received a live or live-attenuated vaccine within 28 days before the first dose of the study drug
• People who require blood-thinning treatment with warfarin or similar vitamin K antagonist medications (certain other blood thinners are allowed)
• People with a diagnosis of primary immunodeficiency, or who are taking high-dose steroid medication or other immune-suppressing treatments within seven days before the first dose
• People with an active autoimmune disease that has required ongoing medical treatment in the past two years (replacement therapies such as thyroid hormone or insulin are generally acceptable)
• People with an uncontrolled autoimmune blood condition where new or increased treatment was needed in the four weeks before joining the study
• People with another active cancer, unless it has been in remission and life expectancy is greater than two years (people with prostate cancer under active monitoring may still be considered)
• People who have not sufficiently recovered from major surgery within the past four weeks, or who have ongoing surgical complications
• People with known psychiatric conditions or substance use disorders that would interfere with following the study requirements
• People with any other condition, medical history, or circumstance that the treating doctor believes could affect the study results or make participation not in the person's best interest

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