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Looking for participantsPhase2

Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy

Sponsor: University of Birmingham

NCT ID: NCT05848765

View on ClinicalTrials.gov ↗

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).

Relapsed Follicular LymphomaRefractory Follicular Lymphoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
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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

CD20CD20 positivePatients positiveDNA negativePSA

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
Inclusion Criteria: 1. Biopsy proven relapsed or refractory CD20 positive, grade 1-3a follicular lymphoma (biopsy within 3 months of trial entry) 2. Aged 18 years or over 3. Advanced disease that in the opinion of the treating physician requires treatment 4. Patient suitable for standard available therapy at the Investigator's discretion 5. Prior therapy with at least one line of immunochemotherapy. Previous radiotherapy at any time is permitted and will not count as a line of therapy. Previous rituximab monotherapy is also permitted as long as patients have at any time also received at least one line of immunochemotherapy 6. Assessable disease by PET-CT (at least one involved node with long diameter \>1.5cm, or extranodal lesion \>1cm ) 7. ECOG performance status of 0, 1 or 2 at trial entry 8. Adequate organ function defined as; i. ANC ≥ 1.0 x 109/L (growth factor use is permitted) ii. Platelet count ≥ 75 x 109/L, or ≥ 50 x 109/L if bone marrow infiltration or splenomegaly iii. ALT and AST level ≤3 x ULN iv. Direct bilirubin level ≤ 2 x ULN, unless due to Gilbert's syndrome v. CrCl ≥ 50mL/min (by Cockcroft-Gault formula) vi. PT, INR and aPTT ≤ 1.5 x ULN, unless receiving anticoagulation vii. LVEF within normal limits by MUGA or echocardiography 9. Able to provide written informed consent 10. Women of childbearing potential (or their partners) must use an effective form of contraception Exclusion Criteria: 1. Current (or within 1 year) transformation to high grade lymphoma, including grade 3b follicular lymphoma (patients with historical high-grade transformation over 1 year ago are eligible) 2. Non-Fluorodeoxyglucose (FDG) avid disease 3. Prior allogenic stem cell transplantation (SCT) or solid organ transplant 4. Prior treatment with lenalidomide 5. Treatment with CAR-T therapy within 100 days of starting trial treatment 6. SCT or maintenance therapy planned within 24 weeks of starting treatment (patients planning SCT/maintenance after at least 24 weeks of treatment are eligible) 7. Immunochemotherapy with a platinum-containing regimen planned 8. Known serological positivity for HIV or uncontrolled HCV 9. Hepatitis B surface antigen (HBsAg) positive and/or detectable viral DNA. Patients positive for Hepatitis B core antibody (anti-HBc) but viral DNA negative are eligible 10. Other malignancy within 2 years of enrolment, excepting cervical carcinoma stage 1B or less, non-invasive basal cell or squamous cell skin carcinoma, non-invasive, superficial bladder cancer, prostate cancer with a current PSA level \<0.1ng/mL, any curable cancer with a CR of \> 2 years duration 11. Active systemic infection requiring treatment 12. Current or prior CNS involvement with lymphoma 13. History of allergy or anaphylaxis to anti-CD20 monoclonal antibody therapy 14. Known hypersensitivity to any of the experimental arm IMPs. Patients with a known hypersensitivity to a control arm regimen may still be eligible if they have no hypersensitivity to other potential control arm IMPs. 15. Serious medical or psychiatric illness likely to interfere with participation in this clinical study 16. Recent cancer treatment (chemotherapy, immunotherapy, biological therapy) within 4 weeks of starting trial treatment; systemic steroid treatment (prednisolone \> 10mg daily (or equivalent)) within 7 days of cycle 1 day 1 dosing 17. Unwilling to use appropriate contraception methods whilst on study treatment and for 12 months following end of treatment (or 18 months for female patients whose ICT regimen contains obinutuzumab) 18. Women who are pregnant or breastfeeding 19. Prior treatment with the experimental therapy under investigation 20. Major surgery within 30 days of starting treatment 21. Severe arrhythmias, heart failure, previous myocardial infarction, acute inflammatory heart disease for ICT regimen containing doxorubicin, or severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease for ICT regimen containing rituximab

Where Is This Study? (25 UK sites)

NHS Grampian

Aberdeen, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Fiona Brebner

gram.randd@nhs.scot01224 551121

Belfast Health & Social Care Trust

Belfast, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Alison Murphy

alison.murphy@belfasttrust.hscni.net028 9063 6366

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Dr Angela Parker

bfwh.randd.office@nhs.net01253 (9) 51514 / (9) 55547

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Cardiff and vale University LHB

Cardiff, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Sarah Martin

research.development@wales.nhs.uk029 2074 6986

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Josie Goodby

research@uhcw.nhs.uk02476 965244

Croydon Health Services NHS Trust

Croydon, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Non Portfolio - Michael Chang Portfolio - South West Cluster Office

ch-tr.research@nhs.net0208 401 3610

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Radek Penar

radoslaw.penar@nhs.scotn/a

The Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Dr Maria Maguire

maria.maguire2@nhs.net0151 556 5321

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

King's College Hospital NHS Foundation Trust

London, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

The Royal Marsden NHS Foundation Trust

London, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

University College London Hospital NHS Foundation Trust

London, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

The Christie NHS Foundation Trust

Manchester, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Research and Development

nuth.genericqueries@nhs.net0191 282 4926

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Julie Dawson

rdsubmissions@nnuh.nhs.uk01603 286611

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

University Hospital of North Midlands NHS Trust

Stoke-on-Trent, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Sarah Jones

studysetup@uhnm.nhs.uk01782 675385

Swansea Bay University Local Health Board

Swansea, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Jemma Rogers

Jemma.Rogers@wales.nhs.uk01792 530890

Torbay and South Devon NHS Foundation Trust

Torquay, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Dr Fiona Roberts (R&D Director)

tsdft.research@nhs.net01803 656635

How to Get in Touch

Trial Coordinator

Sponsor contact

CONTACT

0121 371 7861 refract@trials.bham.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-04