A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

To be considered for this study, you would need to have been diagnosed with diffuse large B-cell lymphoma (DLBCL) that has either returned or has not responded to at least one previous treatment. If you've only had one previous treatment, you must not be suitable for a high-dose chemotherapy followed by a stem cell transplant.

Doctors would also need to confirm that they can get a sample of your cancer tissue for testing, preferably new, but older samples might be acceptable. You would need to have at least one measurable area of cancer, visible on scans. Your general health, as assessed by a doctor (known as your ECOG performance status), should be good enough for you to participate, generally meaning you are able to perform most daily activities. Your body systems, like your kidneys and blood counts, would also need to be working adequately, unless issues are due to your lymphoma.

There are also reasons why you might not be able to join. For example, if you've only had one prior treatment and are suitable for a stem cell transplant, or if your DLBCL started from a slower-growing lymphoma. Certain specific types of DLBCL, or a history of severe allergic reactions to similar medications, would also mean you couldn't take part. You would also need a negative COVID-19 test before joining.

If you join this study, you will receive treatment over several months. You will have regular hospital visits for treatments, blood tests, scans, and check-ups to monitor your health and how you are responding to the medication. The study involves different medicines: glofitamab, obinutuzumab, rituximab, tocilizumab, gemcitabine, and oxaliplatin. The specific combination you receive will be decided by chance, like flipping a coin, so it's fair. After completing the main treatment period, you will have a follow-up period where you'll continue to have check-ups to see how you are doing in the long term. The exact number of visits and the full duration of your participation will be explained in detail by the study team, but generally, participation involves active treatment for several months followed by a longer monitoring period.