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

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Biopsy proven relapsed or refractory CD20 positive, grade 1-3a follicular lymphoma (biopsy within 3 months of trial entry)

• 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

• 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

• Assessable disease by PET-CT (at least one involved node with long diameter \>1.5cm, or extranodal lesion \>1cm )

• ECOG performance status of 0, 1 or 2 at trial entry

• 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

• Able to provide written informed consent

⁃ Women of childbearing potential (or their partners) must use an effective form of contraception

Locations
Other Locations
United Kingdom
NHS Grampian
NOT_YET_RECRUITING
Aberdeen
Belfast Health & Social Care Trust
NOT_YET_RECRUITING
Belfast
University Hospitals Birmingham NHS Foundation Trust
NOT_YET_RECRUITING
Birmingham
Blackpool Teaching Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Blackpool
Cambridge University Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Cambridge
Cardiff and vale University LHB
NOT_YET_RECRUITING
Cardiff
University Hospitals Coventry and Warwickshire NHS Trust
NOT_YET_RECRUITING
Coventry
Croydon Health Services NHS Trust
NOT_YET_RECRUITING
Croydon
NHS Greater Glasgow and Clyde
NOT_YET_RECRUITING
Glasgow
The Leeds Teaching Hospitals NHS Trust
NOT_YET_RECRUITING
Leeds
The Clatterbridge Cancer Centre NHS Foundation Trust
NOT_YET_RECRUITING
Liverpool
Guy's and St Thomas' NHS Foundation Trust
NOT_YET_RECRUITING
London
King's College Hospital NHS Foundation Trust
NOT_YET_RECRUITING
London
The Royal Marsden NHS Foundation Trust
NOT_YET_RECRUITING
London
University College London Hospital NHS Foundation Trust
NOT_YET_RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Newcastle
Norfolk and Norwich University Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Norwich
Nottingham University Hospitals NHS Trust
RECRUITING
Nottingham
Oxford University Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Oxford
Sheffield Teaching Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Sheffield
University Hospital Southampton NHS Foundation Trust
NOT_YET_RECRUITING
Southampton
University Hospital of North Midlands NHS Trust
NOT_YET_RECRUITING
Stoke-on-trent
Swansea Bay University Local Health Board
NOT_YET_RECRUITING
Swansea
Torbay and South Devon NHS Foundation Trust
NOT_YET_RECRUITING
Torquay
Contact Information
Primary
Trial Coordinator
refract@trials.bham.ac.uk
0121 371 7861
Time Frame
Start Date: 2023-09-04
Estimated Completion Date: 2031-11-30
Participants
Target number of participants: 284
Treatments
Experimental: Round 1: Epcoritamab and lenalidomide
Epcoritamab (weekly for cycles 1 and 2 and on day 1 of cycles 3-12 for up to 12 cycles) and lenalidomide (daily for days 1-21 of each cycle for up for 12 cycles), cycles will be 28 day cycles.
Experimental: Round 2
Investigation agent 2
Experimental: Round 3
Investigation agent 3
Active_comparator: All rounds: Investigator Choice Therapy
Choice of therapy to be selected by the Investigator for each patient prior to randomisation. The Investigator will choose between; RCHOP, RCVP, rituximab and bendamustine, rituximab and lenalidomide or bendamustine and obinutuzumab.
Sponsors
Leads: University of Birmingham
Collaborators: Cancer Research UK, Genmab

This content was sourced from clinicaltrials.gov