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Brief Title: Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy
Official 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
Study ID: NCT05848765
Brief Summary: The aim of the REFRACT clinical trial is to find new therapies with improved outcomes compared to the current standard treatment available, in patients with relapsed or refractory follicular lymphoma. This will be done by comparing patients who have received a new treatment against patients who receive standard treatment based on their response to the treatment received.
Detailed Description: In the REFRACT trial patients with relapsed or refractory follicular lymphoma (rrFL) will be randomised (randomly allocated) to receive a new treatment (experimental treatment) or standard treatment which will be chosen by their doctor prior to entering the trial (called investigator choice standard therapy (ICT)). There are 3 treatment rounds which will happen one after another, testing 3 different experimental treatments. The experimental treatment in each round will be compared to ICT. ICT will be a choice of 1 of 5 standard treatment options including RCHOP, RCVP, lenalidomide and rituximab, bendamustine and rituximab or obinutuzumab and bendamustine. Patients in Round 1 (R1) will be randomised using a 1:1 allocation ratio (meaning patients have a 50/50 chance of receiving the experimental treatment). In Round 1 the experimental treatment is epcoritamab combined with lenalidomide. Patients randomised to epcoritamab and lenalidomide will receive up to 12 28-day cycles of therapy; epcoritamab will be delivered as a subcutaneous injection weekly for cycles 1 and 2 and on day 1 of cycles 3-12. Lenalidomide will be taken orally on days 1-21 of each cycle. Patients in Rounds 2 (R2) and 3 (R3) (experimental treatments yet to be determined) will be randomised using a 1:4 allocation ratio in favour of the experimental treatment (meaning patients are more likely to receive the experimental treatment). The study will recruit 284 patients with rrFL over 5 years. The aim is to identify new therapies which have better outcomes compared to ICT based on patients response to treatment (tested by PET scan) after 24 weeks of therapy. Following treatment patients will be followed up yearly until the end of the trial (up to 10 years).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
NHS Grampian, Aberdeen, , United Kingdom
Belfast Health & Social Care Trust, Belfast, , United Kingdom
University Hospitals Birmingham NHS Foundation Trust, Birmingham, , United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust, Cambridge, , United Kingdom
Cardiff and vale University LHB, Cardiff, , United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust, Coventry, , United Kingdom
Croydon Health Services NHS Trust, Croydon, , United Kingdom
NHS Greater Glasgow and Clyde, Glasgow, , United Kingdom
The Leeds Teaching Hospitals NHS Trust, Leeds, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust, London, , United Kingdom
King's College Hospital NHS Foundation Trust, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
University College London Hospital NHS Foundation Trust, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle, , United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Oxford University Hospitals NHS Foundation Trust, Oxford, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, , United Kingdom
University Hospital Southampton NHS Foundation Trust, Southampton, , United Kingdom
University Hospital of North Midlands NHS Trust, Stoke-on-Trent, , United Kingdom
Swansea Bay University Local Health Board, Swansea, , United Kingdom
Torbay and South Devon NHS Foundation Trust, Torquay, , United Kingdom