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 18 years of age or older at the time of signing the consent form.
• People who have been diagnosed with a specific type of large B-cell lymphoma (DLBCL) that has been confirmed by a tissue or fluid sample at the enrolling hospital, including types that affect the brain or spinal cord (confirm with trial site for exact diagnosis requirements).
• People whose general physical functioning falls within an acceptable range as measured by a standard medical scale (ECOG score of 0, 1, or 2 — confirm with trial site what this means for a specific situation).
• People whose blood counts and organ function meet specific minimum levels, including sufficient white blood cells, platelets, red blood cells, and acceptable liver and kidney function — all assessed through blood tests.
• People who have not received a platelet transfusion or red blood cell transfusion in the 21 days before signing the consent form.
• People whose blood clotting results are within acceptable ranges (unless already on blood-thinning medication).
• People whose kidney function meets a minimum clearance level based on age, weight, and blood test results.
• Women who could become pregnant must agree to use highly effective birth control during treatment and for 30 days after the last dose of the study drug.
• Men who are sexually active must agree to use highly effective birth control during treatment and for 3 months after the last dose of the study drug.
• Women who could become pregnant must have a negative blood pregnancy test before starting the trial, and again within 48 hours before the first dose.
• People who are able to tolerate MRI or CT scans.
• People who have difficulty making decisions for themselves may still be considered for enrollment (confirm with trial site).
• People who do not have an active COVID-19 (SARS-CoV-2) infection, or who have tested negative through appropriate testing if symptoms or exposure are present.

Who may not be able to join:

• People who have been newly diagnosed with CNS lymphoma (lymphoma affecting the brain or spinal cord) or non-CNS lymphoma for the first time — this trial is for people whose disease has returned or not responded to previous treatment.
• People with moderate or severe long-term liver disease (Child-Pugh class B or C).
• People who are currently taking other cancer treatments, whether approved or experimental.
• People who have another active cancer that currently requires treatment.
• People who have received chemotherapy, targeted cancer therapy, or certain antibody-based treatments within the past 4 weeks (or 5 half-lives of the drug, whichever is shorter), or within 6 weeks for certain specific chemotherapy drugs, or who have not yet recovered from side effects of those treatments.
• People who have had radiation therapy to the brain or spinal cord within 21 days before the first dose of the study drug.
• People who require more than 8 mg of dexamethasone (a steroid medication) per day or an equivalent amount of another steroid.
• People who are taking warfarin or similar blood-thinning medications — these must be stopped for at least 7 days before starting the study drug. Low molecular weight heparin (a different type of blood thinner) is permitted. People with inherited bleeding disorders are not eligible.
• People who have eaten grapefruit, grapefruit products, Seville oranges (including marmalade), or starfruit within 3 days before the first dose.
• People who are taking certain medications known to interfere with how the body processes the study drug (moderate or strong CYP3A inhibitors or inducers) — these must be stopped for at least two weeks or 5 half-lives before starting, whichever is shorter.
• People who are taking immune-suppressing medications (such as cyclosporine, tacrolimus, or sirolimus), or who have been taking more than 5 mg per day of prednisone or equivalent for more than 12 months — these must be stopped for at least 28 days before the first dose.
• People who have significant heart problems, including uncontrolled irregular heartbeat, heart failure, uncontrolled high blood pressure, valve disease, inflammation around the heart, or a heart attack within the past 6 months.
• People whose heart pumping function (ejection fraction) is below 50%.
• People with a known inherited bleeding disorder such as von Willebrand disease or haemophilia.
• People who have HIV.
• People with a history of active or chronic hepatitis C or hepatitis B infection, based on blood tests.
• People with an uncontrolled active infection.
• People who are unable to swallow capsules, or who have a condition that significantly affects the ability to absorb medications through the digestive system (such as removal of part of the stomach or bowel, or a complete bowel blockage).
• People with a serious illness or organ problem that the trial doctor believes could put their safety at risk or affect the trial results.
• People who have received a live vaccine within 28 days before the first dose, or who are expected to need a live vaccine during participation or within 3 months after the last dose (note: certain COVID-19 vaccines are permitted with appropriate timing — confirm with trial site).
• Women who are pregnant or breastfeeding.

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