Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma

To join this study, you must have been diagnosed with Primary Central Nervous System Lymphoma (PCNSL) confirmed by tests. You need to be 18 years old or older. Importantly, you must not be able to have a stem cell transplant, either because you are 65 or older, or because you have other health issues that make that treatment unsuitable for you.

You also need to be well enough to receive the study drugs, including methotrexate, ibrutinib, and rituximab, as decided by your doctor. You should have clear signs of the cancer on a scan. If you've had some initial treatment for PCNSL, like one cycle of methotrexate with or without rituximab, you might still be able to join, but you need to do so within four weeks of that first dose.

If you decide to take part in this study, for the first three months you'll receive a combination of medicines: methotrexate, ibrutinib, and rituximab (if rituximab is typically used for PCNSL in your area). After these three months, you will continue to take ibrutinib on its own for up to two years in total.

Throughout the study, and even after you finish taking the study drugs (or if you stop early), your study doctor will continue to look after you. This follow-up will last for the rest of your life or for about six years, whichever comes first, to monitor your health and any long-term effects. If you experience any side effects that might be linked to ibrutinib, you'll have check-ups at the clinic every three months until those side effects improve. If you don't have any ibrutinib-related side effects, you'll visit the clinic every six months until your cancer gets worse, and after that, you might have phone check-ups every six months.