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 are able to understand the study and are willing to sign a written consent form before any study-related procedures begin.
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete required tests throughout the study.
• People who are at least 18 years old at the time of signing the consent form.
• People who have been diagnosed with primary central nervous system lymphoma (a type of lymphoma affecting the brain or spinal cord) that has come back or stopped responding to previous treatment directed at the brain or central nervous system, with evidence of this on a brain scan (MRI) or spinal fluid test. Cases where the lymphoma has returned only in the eye are also allowed.
• People whose general physical functioning is rated at a good to near-normal level on a standard doctor-assessed scale (ECOG score of 0 or 1).
• People whose life expectancy is estimated by the treating doctor to be more than 3 months.
• People whose side effects from previous treatments have settled down to a mild level (Grade 1 or lower).
• People who are able to tolerate a lumbar puncture (a procedure to collect spinal fluid) and/or a tap through a device placed in the skull called an Ommaya reservoir.
• People whose blood counts and organ function (including kidneys, liver, and blood clotting) meet the minimum levels required by the study, as measured by blood tests done within 28 days before treatment starts (confirm specific values with trial site).
• Women who could become pregnant must have a negative blood pregnancy test within 72 hours before enrolling.
• Women who could become pregnant must agree to use a highly effective form of contraception throughout the treatment period and for 120 days after the last dose.
• Male participants must agree to use contraception from the first dose through 120 days after the last dose.

Who may not be able to join:

• People who are unable to have an MRI scan of the brain.
• People who have previously been treated with certain immune checkpoint therapies (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or similar immunotherapy drugs that affect T-cell activity, such as those targeting CTLA-4 or CD137).
• People whose lymphoma got worse while they were taking ibrutinib or another drug from the same class (BTK inhibitors). People who took these drugs but did not progress on them may still be eligible.
• People who have had a significant bleed inside the brain (greater than Grade 2 severity).
• People taking the blood thinner warfarin or related warfarin-based medications within 7 days before starting treatment. Some other blood thinners (such as apixaban, dabigatran, rivaroxaban, or low molecular weight heparin) are allowed.
• People who have had a stroke or other serious arterial blood clot event within 3 months before starting the study.
• People with an active autoimmune disease that currently requires immune-suppressing medications or steroids above a certain dose (more than 10 mg of prednisone or equivalent per day).
• People who have needed systemic treatment for an autoimmune disease within the past 2 years (note: hormone replacement therapies such as thyroid or insulin are not considered systemic treatment in this context).
• People who need high-dose steroid treatment specifically for their lymphoma (dexamethasone above 4 mg per day or equivalent for more than 3 days in a row within 2 weeks of enrolling).
• People who have received other anti-cancer treatments or investigational drugs within 4 weeks (or 5 half-lives of the drug, whichever is shorter) before the first study dose.
• People who had major surgery within 2 weeks before starting the study, or who plan to have major surgery within 2 weeks of the first dose.
• People who have not recovered from radiation therapy side effects, or who received radiation to the brain within 2 weeks before starting the study. A short gap may be permitted for limited palliative radiation to areas outside the brain (confirm with trial site).
• People who received a live vaccine (such as measles, mumps, rubella, chickenpox, yellow fever, or live nasal flu spray) within 30 days before the first dose. Standard injected flu vaccines are generally allowed.
• People who have another active cancer that is progressing or has required treatment within the past 3 years. Some early-stage or treated skin or surface cancers may still be eligible (confirm with trial site).
• People who have had a severe allergic reaction (Grade 3 or higher) to any of the study drugs or their ingredients.
• People who have a history of lung inflammation (pneumonitis) that required steroids, or who currently have pneumonitis.
• People with an active, uncontrolled serious infection, or who recently completed intravenous antibiotic or antiviral treatment within 14 days before the first dose.
• People with serious heart problems, such as uncontrolled irregular heartbeat, significant heart failure, unstable chest pain, or a heart attack within the past 6 months.
• People with high blood pressure that is not controlled despite appropriate medication.
• People with poorly controlled diabetes, indicated by a blood sugar control reading (HbA1c) above 8%.
• People with wounds, ulcers, or bone fractures that are not healing.
• People with known bleeding disorders such as von Willebrand's disease or haemophilia.
• People who are unable to swallow capsules, or who have significant problems absorbing food or medication through their digestive system.
• People currently taking certain medications or eating foods that strongly affect how the study drugs are broken down in the body (specifically, strong or moderate CYP3A4/5 inhibitors or inducers). These would need to be stopped 2 weeks before starting the study.
• People taking certain seizure medications that affect drug metabolism (enzyme-inducing antiepileptic drugs) unless they have been switched to an alternative for at least 2 weeks before starting the study.
• People with a known history of HIV/AIDS.
• People with a known history of active Hepatitis B or Hepatitis C infection.
• People with a known history of active tuberculosis (TB).
• People with any other medical condition, ongoing therapy, or lab result that the treating doctor believes could interfere with the study or make participation unsafe.
• People with a diagnosed immune deficiency condition, or who are taking systemic steroids at a dose above 10 mg of prednisone per day on an ongoing basis.
• People who have previously received an allogeneic stem cell transplant (a transplant using donor cells).
• People with known psychiatric conditions or substance use disorders that would make it difficult to follow the study requirements.
• People who are currently pregnant, breastfeeding, or planning to become pregnant or father a child during the study period and for 120 days after the last dose.

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