Phase 2 Lymphoma Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older
• People who have been diagnosed with Waldenström's macroglobulinemia (WM) or lymphoplasmacytic lymphoma (LPL) confirmed by a tissue biopsy, who have not yet received any treatment for this condition
• People whose disease can be measured — either through a lymph node of a certain size or a protein level in the blood called IgM being above a set level
• People whose condition has reached a point where treatment is considered necessary, such as having low red blood cell counts, low platelet counts, nerve problems related to WM, symptoms of thickened blood, kidney problems from WM, large areas of disease, or significant symptoms like fatigue or weight loss
• People who are reasonably able to carry out daily activities (as rated on a standard scale used by doctors, confirm with trial site)
• People whose platelet count, red blood cell level, and white blood cell count meet minimum levels set by the trial (without having had a transfusion or medication to boost those levels in the 7 days before testing)
• People whose liver function test results and kidney function are within acceptable ranges as defined by the trial
• People whose blood clotting test results are within acceptable ranges
• People who are able to understand the study and are willing to sign a consent form
• People who are able to swallow pills
• People who have a positive Hepatitis B surface antibody due to a past vaccination, or people who have a certain Hepatitis B antibody but have a negative viral test result and are on antiviral treatment
• People of reproductive potential, and their partners, who are willing to use highly effective birth control during treatment and for one year after the last dose

Who may not be able to join:

• People who have previously received any systemic (whole-body) treatment for their condition
• People who have had major surgery within 4 weeks before starting treatment
• People with a history of abnormal bleeding or clotting disorders
• People who previously experienced a serious bleeding event or a severe heart rhythm problem while taking a type of drug called a BTK inhibitor
• People who have had a stroke or bleeding in the brain within 6 months before starting treatment
• People who have had a stem cell transplant or a specialised immune cell therapy (CAR-T) within 60 days before starting, or who still have certain ongoing complications from those treatments (such as graft-versus-host disease, incomplete blood count recovery, or ongoing immune-suppressing medication above a certain dose)
• People with serious heart conditions, including unstable chest pain or a heart attack within the past 2–3 months, significantly reduced heart pumping function, severe heart failure, or uncontrolled heart rhythm problems
• People with a specific abnormality in a heart electrical measurement (QTcF interval above 470 milliseconds), unless a correction can be safely made (confirm with trial site)
• People who have tested positive for HIV, or whose HIV status is unknown and who test positive at screening
• People with an active Hepatitis B infection (positive surface antigen or positive viral DNA test)
• People with an active Hepatitis C infection (positive antibody and positive RNA test)
• People with a known active CMV (cytomegalovirus) infection
• People who are pregnant or planning to become pregnant during the study or within 1 month of the last dose
• People who are breastfeeding or planning to breastfeed during the study or within 1 week of the last dose
• People with a significant condition that affects how the gut absorbs medication
• People with serious uncontrolled infections (bacterial, viral, fungal, or parasitic, excluding fungal nail infections) or other significant active health conditions that the trial doctors consider a risk
• People with active uncontrolled immune-related blood count problems (such as the immune system attacking red blood cells or platelets) where treatment for that condition was started or increased within 4 weeks before joining the trial
• People with another active cancer, unless it is in remission and life expectancy is greater than 2 years
• People who require ongoing blood-thinning treatment with warfarin or a similar type of medication (vitamin K antagonist)
• People who have received a live vaccine within 28 days before starting treatment
• People with a known allergy to the study drug (Pirtobrutinib) or any of its ingredients, or to other planned study medications
• People who are currently taking, or have taken within 7 days before the first dose, certain medications that affect how the study drug is processed by the body (moderate or strong CYP3A inducers or inhibitors, or P-gp inhibitors — confirm specific medications with the trial site)

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