At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Epcoritamab (drug), Lenalidomide (drug), Rituximab (drug), Obinutuzumab (drug)
- How long the study runs
- Study runs about 98 months (dates as stated)
- About the drug or intervention
- Epcoritamab — drug: Bispecific antibody · Lenalidomide — drug: Immunomodulatory agent · Rituximab — drug: Monoclonal antibody · Obinutuzumab — drug: Monoclonal antibody · Bendamustine — drug: Alkylating agent (chemotherapy drug) · Vincristine — drug: Antineoplastic, Vinca Alkaloid · Doxorubicin — drug: Anthracycline · Cyclophosphamide — drug: Alkylating agent (chemotherapy drug) · Prednisone — drug: Corticosteroid · Investigation agent 2 — drug: The drug used in round 2 is yet to be confirmed, round 2 is estimated to open in Q4 2025 and the record will be updated when the drug has been confirmed · Investigation agent 3 — drug: The drug used in round 3 is yet to be confirmed, round 3 is estimated to open in Q3 2027 and the record will be updated when the drug has been confirmed
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 284
- Started
- 2023-09-04
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for relapsed follicular lymphoma
- • Phase2 - 284 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with relapsed follicular lymphoma
Where?
- • Aberdeen - NHS Grampian
- • Belfast - Belfast Health & Social Care Trust
- • Birmingham - University Hospitals Birmingham NHS Foundation Trust
- • Blackpool - Blackpool Teaching Hospitals NHS Foundation Trust
- • +21 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ treatment
- ✓ at least one line of immunochemotherapy
What the study is looking for
- ✓Biopsy proven relapsed or refractory CD20 positive, grade 1-3a follicular lymphoma (biopsy within 3 months of trial...
- ✓Aged 18 years or over
- ✓Advanced disease that in the opinion of the treating physician requires treatment
- ✓Patient suitable for standard available therapy at the Investigator's discretion
- ✓Assessable disease by PET-CT (at least one involved node with long diameter \>1.5cm, or extranodal lesion \>1cm )
Who cannot take part
- ✗Current (or within 1 year) transformation to high grade lymphoma, including grade 3b follicular lymphoma (patients...
- ✗Non-Fluorodeoxyglucose (FDG) avid disease
- ✗Prior allogenic stem cell transplantation (SCT) or solid organ transplant
- ✗Prior treatment with lenalidomide
- ✗Treatment with CAR-T therapy within 100 days of starting trial treatment
See the full criteria
Where Is This Study? (25 UK sites)
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
Non Portfolio - Michael Chang Portfolio - South West Cluster Office
ch-tr.research@nhs.net0208 401 3610NHS 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
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825The 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
How to Get in Touch
Trial Coordinator
Sponsor contactCONTACT
