Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy

To join the REFRACT trial, you must be 18 years or older and have follicular lymphoma that has either returned or not responded to previous treatment. This must be confirmed by a recent biopsy, and your lymphoma needs to show up on a specific type of scan (PET-CT).

You should also be generally well enough to tolerate treatment, as judged by your doctor, and have received at least one course of a specific type of chemotherapy called 'immunochemotherapy' in the past. Your blood tests and organ functions (like your kidneys and liver) must be within a healthy range.

However, you cannot join if your lymphoma has recently changed into a more aggressive type, or if you've had certain complex treatments like a bone marrow transplant or specific cell therapies (like CAR-T), unless it was a long time ago. Also, if you've already had a drug called lenalidomide, you won't be able to participate. Women of childbearing potential, or their partners, must agree to use effective contraception.

If you decide to take part in the REFRACT trial, you will be randomly assigned to either receive an experimental new treatment or one of the standard treatments. The chance of getting the experimental treatment depends on which stage of the trial you join; in the first stage, it's a 50/50 chance. The experimental treatment in the first stage involves epcoritamab given as an injection under the skin and lenalidomide taken as a pill, typically over 12 cycles, each lasting 28 days. Follow-up appointments and scans will be part of the process to monitor your health and how your lymphoma is responding to treatment. After your treatment period, you will have yearly check-ups for up to 10 years to see how you are doing in the long term, even after the treatment itself has finished.