Phase 2 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 have been diagnosed with primary central nervous system (CNS) lymphoma (a type of cancer affecting the brain or spinal cord), confirmed by a tissue or fluid sample, including those with eye involvement or cancer cells in the spinal fluid, as long as brain involvement is shown on an MRI scan.
• People aged 18 or older.
• People who are not suitable for high-dose chemotherapy with a stem cell transplant — either because they are 65 or older, or because of other health conditions — but who their treating doctor considers well enough to receive the study treatment combination.
• People who agree to allow a tumour tissue sample (if available) to be sent for study purposes, and whose treating centre/pathologist has agreed to submit the specimen.
• People who have disease visible on imaging, or who are planned to receive standard-of-care methotrexate/rituximab treatment even if imaging is unclear after surgery.
• People who have received at most one cycle of methotrexate (with or without rituximab) as standard care before joining, provided they enrol within 4 weeks of that first dose.
• People who have received a steroid medication (such as dexamethasone) at a dose no higher than 8mg per day, as long as it can be fully stopped within 7 days of starting the study treatment.
• People who have received a one-time injection of chemotherapy into the spinal fluid at the time of diagnosis — no waiting period is required before joining.
• People who have had major surgery at least 28 days before joining (this waiting period does not apply to surgery on the brain for this cancer, which can be followed by study treatment when the treating doctor considers it safe).
• People who have not previously had radiation therapy for this CNS lymphoma.
• People with a general health/functioning score (ECOG) of 0–2, or a score of 3 if it is caused directly by the CNS lymphoma and is expected to improve with treatment.
• People who are able to swallow tablets/capsules and have no known gut conditions that would stop medications from being properly absorbed.
• People whose recent blood and organ function test results (taken within 7 days before joining) meet the required levels for blood cells, liver function, and kidney function.
• People who are able and willing to complete quality-of-life questionnaires in English or French.
• People who are able to attend the participating treatment centre for all treatment visits and follow-up appointments.
• People of childbearing potential who have agreed to use a highly effective method of contraception.
• People with a history of hepatitis B (showing past exposure in blood tests) who are confirmed to have no active virus in the blood and are receiving or will receive antiviral treatment (confirm with trial site).
• People with a history of hepatitis C that has been fully treated and is no longer active.
• People who are HIV-positive, provided they have been on effective HIV treatment for at least 4 weeks before joining, their HIV viral load is below 400 copies/ml within the past 16 weeks, their HIV medications are not known to interact with the study drug ibrutinib, and they have had no serious infections related to HIV in the past year.

Who may not be able to join:

• People whose lymphoma has spread to the CNS from somewhere else in the body (i.e., it did not start in the CNS).
• People with significant fluid build-up in the chest or abdomen that cannot be adequately drained before receiving methotrexate.
• People who are currently receiving active treatment for another advanced or metastatic cancer.
• People with a known allergy or sensitivity to any of the study drugs or their ingredients.
• People who have had an active, uncontrolled bacterial, fungal, or viral infection within 7 days before joining.
• People with HIV who have a CD4 immune cell count below 350 cells per microlitre.
• People with HIV who have had a serious opportunistic infection in the past year.
• People with serious illnesses or health conditions that would prevent them from safely following the study treatment plan.
• People who need to receive other anti-cancer treatments or experimental therapies at the same time as the study treatment.
• People who have previously had a bone marrow transplant from a donor, or a double umbilical cord blood transplant.
• People who are pregnant or breastfeeding.
• People who require blood-thinning medication with warfarin or similar vitamin K antagonist drugs.
• People who require ongoing treatment with a strong CYP3A inhibitor or inducer medication (a category of drugs that can interfere with how the study drug is processed in the body — confirm with trial site for the specific list).
• People who require steroid medication at a dose greater than 8mg of dexamethasone per day (or equivalent) at the time of joining.
• People who take fish oil or vitamin E supplements, or regularly consume grapefruit juice (these must be avoided).
• People who have received a live vaccine within 30 days before joining (or within 30 days before starting pre-study methotrexate/rituximab, if one cycle was received before enrolment).
• People with significant heart conditions, including: chest pain (angina), recent heart attack, heart bypass surgery, stenting or angioplasty within the past 12 months, a history of moderate-to-severe heart failure, cardiomyopathy (disease of the heart muscle), uncontrolled high blood pressure, or irregular heart rhythms (note: people with well-controlled atrial fibrillation may still be eligible — confirm with trial site).
• People with a significant past heart history (other than now-controlled high blood pressure) whose heart pumping function is below 50% on assessment.

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