RecruitingPhase 2NCT05848765

Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy

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

Sponsor

University of Birmingham

Enrollment

284 participants

Start Date

Sep 4, 2023

Study Type

INTERVENTIONAL

Conditions

Refractory Follicular Lymphoma Relapsed Follicular Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing CAR-T cell therapy (a treatment where your own immune cells are modified to fight cancer) against standard chemotherapy for people with follicular lymphoma (a slow-growing blood cancer) that has come back or stopped responding to treatment. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of follicular lymphoma (grade 1–3a) that has relapsed or is not responding to treatment - Your disease requires treatment in your doctor's judgment - You are eligible for standard available therapies (so that either arm of the trial is suitable for you) **You may NOT be eligible if...** - Your follicular lymphoma has transformed into a more aggressive type - You have had a prior CAR-T cell therapy - You have serious organ problems or active infections - You are pregnant or breastfeeding - You are unable to attend the required follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEpcoritamab

Bispecific antibody

DRUGLenalidomide

Immunomodulatory agent

DRUGRituximab

Monoclonal antibody

DRUGObinutuzumab

Monoclonal antibody

DRUGBendamustine

Alkylating agent (chemotherapy drug)

DRUGVincristine

Antineoplastic, Vinca Alkaloid

DRUGDoxorubicin

Anthracycline

DRUGCyclophosphamide

Alkylating agent (chemotherapy drug)

DRUGPrednisone

Corticosteroid

DRUGInvestigation agent 2

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

DRUGInvestigation agent 3

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

Locations(25)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05848765

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