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:

• People who have been diagnosed with mantle cell lymphoma (MCL), a type of blood cancer, confirmed by a tissue biopsy.
• People who are able to swallow and digest oral (by mouth) medications.
• People whose MCL has come back or stopped responding to treatment, including those who have previously received certain targeted therapies (such as BTK inhibitors like ibrutinib, acalabrutinib, or zanubrutinib, or a CAR-T cell therapy targeting CD19), as long as they have not previously received a drug called venetoclax — or people with high-risk MCL based on specific biological features of their cancer (confirm with trial site).
• People aged 18 or older at the time of signing the consent form.
• People who have at least one area of measurable disease visible on scans, or whose MCL is present only in the bone marrow or digestive tract.
• People who are well enough to carry out basic daily activities, as measured by a standard medical scoring tool (ECOG score of 2 or less, meaning the person may have some symptoms but is not fully bedridden).
• People who are free of other cancers, with some exceptions for certain treated skin cancers, early-stage cancers that have been treated and are no longer active, or other cancers that are in remission with a life expectancy related to that cancer of more than 3 years (confirm with trial site).
• People whose blood clotting results are within an acceptable range (no more than 1.2 times the upper limit of normal for the testing facility), with a possible exception for people with a specific clotting condition called lupus anticoagulant (confirm with trial site).
• People whose bone marrow is producing enough blood cells without needing recent transfusions or growth factor support — specifically, platelets at or above 50,000/mm³, neutrophils (a type of white blood cell) at or above 1,000/mm³, and haemoglobin at or above 8 g/dL. If low blood counts are clearly caused by MCL affecting the bone marrow, exceptions may be considered after discussion with the lead doctor.
• People whose kidneys, liver, and other organs are functioning at an acceptable level based on blood test results (confirm with trial site for specific values).
• People expected to live at least 12 weeks based on their lymphoma status.
• Women who are either unable to become pregnant (through surgery or menopause of at least one year), or who have a confirmed negative pregnancy test within 7 days before starting the study treatment.
• People who are willing to use highly effective contraception (birth control) during the study and for at least 6 months after the last dose of study treatment. Acceptable methods include hormonal contraception, intrauterine devices (IUDs), birth control injections, or double barrier methods. Sperm donation is not permitted during the study or for 6 months after the last dose.
• People who have allowed enough time since their last cancer treatment before starting the trial — this varies depending on the type of treatment previously received (confirm with trial site for specific timeframes).
• People whose side effects from previous treatments have mostly resolved to mild or no symptoms (Grade 1 or lower), except for hair loss or mild nerve-related symptoms (Grade 2 peripheral neuropathy).

Who may not be able to join:

• People whose lymphoma has spread to the brain or spinal cord (central nervous system), unless they were previously treated for this, are now neurologically stable, and have no current signs of disease — and only if the lead doctor provides a strong clinical reason and approval is obtained (confirm with trial site).
• People with a history of abnormal bleeding or a condition that makes the blood unable to clot properly.
• People who have had a stroke or bleeding in the brain within the 6 months before starting the trial.
• People who have received a live vaccine within 28 days before joining the trial.
• People who have a known serious allergic reaction to the main study drug (pirtobrutinib) or to the comparison drug used in the trial.
• People who experienced a serious bleeding event or a severe heart rhythm problem (Grade 3 or higher) while previously taking a BTK inhibitor.
• People who are pregnant or currently breastfeeding.
• People with HIV that is not well controlled. People with HIV may be eligible if their immune cell counts are high enough, they have not had a serious HIV-related infection in the past 12 months, their HIV viral load is low, and their HIV medications do not interfere with the study drugs (confirm with trial site).
• People with active hepatitis B or hepatitis C virus infection, based on specific blood test results (confirm with trial site).
• People with serious uncontrolled infections (bacterial, viral, fungal, or parasitic), excluding fungal nail infections.
• People who are pregnant, breastfeeding, or planning to breastfeed during the study or within 6 months of the last dose.
• People with serious heart problems, including unstable chest pain or heart attack within the past 2–3 months, very poor heart pumping function (40% or below), or severe heart failure or uncontrolled heart rhythm problems.
• People whose heart's electrical signal (QT interval) is abnormally prolonged on heart tracing (ECG) tests, above a specific threshold (confirm with trial site).
• People with another active cancer diagnosis within the past year, with some exceptions for certain treated skin cancers, cervical cancer in situ, localised breast cancer in long-term remission, or prostate cancer under active surveillance (confirm with trial site).
• People with conditions that seriously affect the ability to absorb medications through the gut, such as removal of part of the stomach or small intestine, or active inflammatory bowel disease.
• People with known serious allergies to a class of medications called xanthine oxidase inhibitors or to a drug called rasburicase.
• People with other serious medical, psychological, or laboratory conditions that the lead doctor believes would make participation unsafe or would affect the study results.
• People currently receiving other cancer treatments, immunotherapy, cell-based therapies, or radiation therapy, or who have had major surgery within 4 weeks before the first dose.
• People with uncontrolled autoimmune conditions that are causing low blood counts (such as autoimmune haemolytic anaemia or immune thrombocytopenia) and required new or increased treatment within 4 weeks before joining.
• People who have had a stem cell transplant or CAR-T cell therapy within the past 60 days, or who still have active complications from these treatments such as graft-versus-host disease, incomplete blood count recovery, or ongoing immunosuppression above a certain level.
• People with known nerve or neurological conditions that the lead doctor believes could increase the risk of nerve-related side effects during the trial.
• People with an active, uncontrolled systemic infection.
• People who have taken an experimental drug within 2 weeks (or within 5 half-lives of that drug, whichever is shorter) before the first dose of study treatment.
• People currently taking certain strong medications that affect how the body processes the study drugs (CYP3A4 inhibitors or inducers, or P-gp inhibitors). This also includes consuming grapefruit, Seville oranges, or star fruit within 3 days of starting the study treatment.
• People taking blood-thinning medications called warfarin or other vitamin K antagonists, as these cannot be used together with the study drugs.

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