Phase 3 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 are able to understand the study's purpose and risks, and who are willing to sign a consent form agreeing to how their health information will be used.
• People who are willing and able to attend all required study visits and procedures, including being able to swallow capsules and tablets without difficulty.
• People who are over 80 years old, OR people aged 61–80 who a doctor has determined are not suitable for full-dose standard chemotherapy (a treatment called R-CHOP).
• Male patients who are sexually active with women who could become pregnant must agree to use highly effective contraception plus a condom during the study.
• Female patients who could become pregnant and are sexually active must agree to use highly effective contraception during the study.
• People who have been diagnosed — through a biopsy — with a specific type of blood cancer called CD20-positive diffuse large B-cell lymphoma (DLBCL) or a related type of aggressive B-cell lymphoma, and who have not yet received any treatment for it. Several subtypes are included (confirm with trial site for the full list).
• People whose lymphoma is at Stage II, III, or IV, or Stage I with a tumour measuring at least 7.5 cm, based on a standard staging system called Ann Arbor Classification.
• People with a general health and activity level rated as 0, 1, or 2 on a standard medical scale (ECOG), or rated 3 only if that lower function is directly caused by the lymphoma itself.
• People whose blood test results meet specific minimum levels for white blood cells, platelets, liver function, and kidney function — with some exceptions allowed if the lymphoma itself is causing those results (confirm with trial site for exact values).

Who may not be able to join:

• People with serious or uncontrolled health conditions that a doctor believes would make participation unsafe or difficult to complete.
• People with significant heart problems, such as symptomatic irregular heartbeat, heart failure, a heart attack within the past 6 months, severe heart disease, or a heart pumping function below 40%. People with well-controlled, symptom-free atrial fibrillation may still be considered.
• People with severe lung problems not caused by the lymphoma.
• People with serious psychiatric or neurological conditions that a doctor believes would make participation unsafe or make it hard to follow the study requirements.
• People with severe, ongoing nerve damage (rated grade 3 or 4 on a standard medical scale).
• People with persistent nausea and vomiting, difficulty swallowing, serious ongoing gut or bowel problems, or who have had certain stomach or bowel surgeries that could affect how the body absorbs the study drug.
• People with a history of another cancer that could interfere with the study, unless it was a skin cancer or early-stage cancer that was fully treated and has been in remission for at least 2 years (or 5 years if chemotherapy was used), or certain low-risk cancers requiring only monitoring.
• People who have received a live virus vaccine within 28 days before entering the trial.
• People with a known history of HIV infection.
• People with any active significant infection (bacterial, viral, or fungal) at the time of joining.
• People with a history of, or ongoing, a serious brain condition called progressive multifocal leukoencephalopathy (PML).
• People with active hepatitis B or hepatitis C infection. Some people with certain hepatitis B markers may still be considered if specific blood test results are negative (confirm with trial site).
• People who have had a stroke or bleeding in the brain within the 6 months before entering the trial.
• People with a history of significant bleeding disorders, such as haemophilia or von Willebrand disease.
• People who have had major surgery within the 30 days before entering the trial.
• People who are pregnant or breastfeeding.
• People with any life-threatening illness, serious personal circumstance, or social or financial situation that a doctor believes could put the person or the study at risk.
• People whose lymphoma has spread to the brain or spinal fluid, or who have been diagnosed with a specific type called primary central nervous system lymphoma.
• People diagnosed with a condition called Richter's Transformation or transformed chronic lymphocytic leukaemia (CLL).
• People currently taking a blood-thinning medication called warfarin or similar vitamin K-blocking drugs. Certain other blood thinners (such as low molecular weight heparin, direct oral anticoagulants, or low-dose aspirin) are permitted, and switching from warfarin to an allowed alternative before the trial may be possible (confirm with trial site).
• People who require treatment with certain medications that strongly affect how the body processes drugs (strong CYP3A inhibitors or inducers), or who have taken these within a specific time window before starting the study drug.
• People who have previously been treated with a type of drug called a BTK inhibitor.
• People who have previously received a high cumulative dose of a class of chemotherapy drugs called anthracyclines (300 mg/m² or more).
• People who have already started lymphoma treatment, except for limited pre-phase treatment with steroids, vincristine, or rituximab within specific dose limits (confirm with trial site).
• People currently participating in another clinical treatment trial.
• People who require ongoing treatment with proton-pump inhibitors (such as omeprazole or pantoprazole). People who are able to switch to a different type of acid-reducing medication (H2-receptor antagonists or antacids) may still be considered.
• People who have received any experimental drug within 30 days, or within 5 half-lives of that drug (whichever is shorter), before starting the study drug.

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