REFRACT
Research type
Research Study
Full title
Relapsed Follicular lymphoma Randomised trial Against standard ChemoTherapy (REFRACT): A randomised phase II trial of investigator choice standard therapy versus sequential novel therapy experimental arms
IRAS ID
1005957
Contact name
Birgit Whitman
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2022-000677-75
Clinicaltrials.gov Identifier
Research summary
Follicular lymphoma (FL) is a slow growing incurable cancer of the immune system. Treatment can control the disease, but most people need more treatment when the disease returns (relapses) or some people don’t respond well to initial treatment (refractory disease). Most people have more chemotherapy with an antibody treatment (standard care), but it is not clear which chemotherapy choice is best overall. There are many non-chemotherapy drugs in development, but we do not yet have trials to tell us if these are better than standard care. This trial will investigate three experimental non- chemotherapy treatments (one after the other in three treatment rounds) and compare them to standard care to find out which treatments are best for FL, safe and associated with a good quality of life. Patients with relapsed or refractory FL (rrFL) will take part and will be randomly assigned to receive standard care or an experimental non-chemotherapy treatment. The experimental treatment for round 1 is epcoritamab combined with lenalidomide. Epcoritamab is a new drug that works by targeting two cancer antigens (molecules) to disrupt cancer progression or development. Lenalidomide is licensed for use in rrFL and can sometimes be received as part of standard care. Research shows that epcoritamab works at least as well as standard care, and combining it with lenalidomide can enhance the effects. The benefit of this treatment over standard care may be fewer side effects and more convenient delivery (may be received as an injection compared to some chemotherapy treatments which are via infusion over a few hours). The drugs for future treatment rounds are not yet known. Around 30 hospitals in the UK will be open to the study, and patients will enter the study over a 5 year period.
REC name
London - Fulham Research Ethics Committee
REC reference
22/LO/0918
Date of REC Opinion
16 May 2023
REC opinion
Further Information Favourable Opinion