The REFRACT trial: implementation of Bayesian power priors in a randomised, sequential phase II adaptive platform trial.
Charlotte Gaskell, Kim Linton, Mark Bishton...
https://pubmed.ncbi.nlm.nih.gov/40319227Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID05848765
Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy (REFRACT): Comparing Investigator Choice Standard Therapy Versus Sequential Experimental Treatments
Led by University of Birmingham · Updated on 2026-05-05
284
Participants Needed
25
Research Sites
130 weeks
Total Duration
On this page
Sponsors
U
University of Birmingham
Lead Sponsor
C
Cancer Research UK
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating new treatments for patients with relapsed or refractory follicular lymphoma, aiming to find better options than the current standard therapies. This Phase II trial compares experimental therapies to standard treatments chosen by doctors before the trial. The study focuses on how patients respond to treatment, measured by PET scans after 24 weeks, to identify therapies that may improve outcomes. Patients will be randomly assigned to receive either an experimental treatment or one of five standard therapy options, such as RCHOP or bendamustine with rituximab. In the first treatment round, patients may receive epcoritamab by weekly injection combined with oral lenalidomide in 28-day cycles, up to 12 cycles. Subsequent rounds will test other new treatments, with patients more likely to receive the experimental option. The trial plans to enroll 284 patients and follow them for up to 10 years. Participants will undergo assessments including PET-CT scans, blood tests, and quality of life questionnaires before and during treatment. Researchers will track treatment responses, survival, adverse effects, and quality of life over the study period. After treatment, patients will be followed yearly to monitor long-term outcomes and any new treatments needed, with total participation lasting up to a decade.
CONDITIONS
Brief Title
Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Biopsy proven relapsed or refractory CD20 positive, grade 1-3a follicular lymphoma within 3 months prior to trial entry
- Age 18 years or older
- Advanced disease requiring treatment as judged by treating physician
- Suitable for standard available therapy as determined by Investigator
- Prior treatment with at least one line of immunochemotherapy
- Assessable disease by PET-CT with at least one involved node >1.5cm or extranodal lesion >1cm
- ECOG performance status of 0, 1, or 2 at trial entry
- Adequate organ function including ANC ≥ 1.0 x 10^9/L, platelet count ≥ 75 x 10^9/L (or ≥ 50 x 10^9/L if bone marrow infiltration or splenomegaly), ALT and AST ≤ 3 x ULN, direct bilirubin ≤ 2 x ULN unless Gilbert's syndrome, CrCl ≥ 50 mL/min, PT, INR and aPTT ≤ 1.5 x ULN unless anticoagulated, and normal LVEF
- Able to provide written informed consent
- Women of childbearing potential and partners must use effective contraception
You will not qualify if you...
- Transformation to high grade lymphoma within past year, including grade 3b follicular lymphoma
- Non-FDG avid disease
- Prior allogenic stem cell or solid organ transplant
- Prior treatment with lenalidomide
- CAR-T therapy within 100 days prior to trial treatment
- Planned stem cell transplant or maintenance therapy within 24 weeks of starting treatment
- Planned immunochemotherapy with platinum-containing regimen
- Known HIV positivity or uncontrolled hepatitis C infection
- Hepatitis B surface antigen positive or detectable viral DNA
- Other malignancy within 2 years except certain early-stage or non-invasive cancers
- Active systemic infection requiring treatment
- Current or prior lymphoma involvement of central nervous system
- History of allergy or anaphylaxis to anti-CD20 monoclonal antibody therapy
- Known hypersensitivity to experimental or control arm medications
- Serious medical or psychiatric illness interfering with participation
- Recent cancer treatment within 4 weeks or systemic steroids within 7 days prior to treatment
- Unwillingness to use contraception during and up to 12-18 months after treatment
- Pregnant or breastfeeding women
- Prior treatment with the experimental therapy under investigation
- Major surgery within 30 days prior to treatment
- Severe heart conditions related to planned treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Round 1 Treatment
Duration - Up to 12 cycles of 28 days each
Participants receive up to 12 cycles of treatment with either the experimental therapy (epcoritamab and lenalidomide) or investigator choice standard therapy. Epcoritamab is given as weekly subcutaneous injections during cycles 1 and 2, then on day 1 of cycles 3-12. Lenalidomide is taken orally on days 1 to 21 of each 28-day cycle.
Weekly visits during cycles 1 and 2, then visits on day 1 of cycles 3 to 12
Rounds 2 and 3 Treatment
Duration - Sequential treatment rounds following Round 1; exact durations to be confirmed
Participants may receive experimental treatments in rounds 2 and 3. Details of these treatments will be provided when available. Investigator choice standard therapy is also an option in these rounds.
Visits as per treatment schedule in rounds 2 and 3 (details to be confirmed)
Follow-up
Duration - Up to 10 years
After completing treatment rounds, participants are followed up yearly to monitor long-term outcomes including survival and response to therapy.
Yearly visits for follow-up assessments
Trial Site Locations
Total: 25 locations
1
NHS Grampian
Aberdeen, United Kingdom
Not Yet Recruiting
2
Belfast Health & Social Care Trust
Belfast, United Kingdom
Not Yet Recruiting
3
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Not Yet Recruiting
4
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, United Kingdom
Not Yet Recruiting
5
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Not Yet Recruiting
6
Cardiff and vale University LHB
Cardiff, United Kingdom
Not Yet Recruiting
7
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, United Kingdom
Not Yet Recruiting
8
Croydon Health Services NHS Trust
Croydon, United Kingdom
Not Yet Recruiting
9
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Not Yet Recruiting
10
The Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Not Yet Recruiting
11
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
Not Yet Recruiting
12
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Not Yet Recruiting
13
King's College Hospital NHS Foundation Trust
London, United Kingdom
Not Yet Recruiting
14
The Royal Marsden NHS Foundation Trust
London, United Kingdom
Not Yet Recruiting
15
University College London Hospital NHS Foundation Trust
London, United Kingdom
Not Yet Recruiting
16
The Christie NHS Foundation Trust
Manchester, United Kingdom
Actively Recruiting
17
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom
Not Yet Recruiting
18
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, United Kingdom
Not Yet Recruiting
19
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Actively Recruiting
20
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Not Yet Recruiting
21
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Not Yet Recruiting
22
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
Not Yet Recruiting
23
University Hospital of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom
Not Yet Recruiting
24
Swansea Bay University Local Health Board
Swansea, United Kingdom
Not Yet Recruiting
25
Torbay and South Devon NHS Foundation Trust
Torquay, United Kingdom
Not Yet Recruiting
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Research Team
T
Trial Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
Investigator choice of standard therapy versus sequential novel therapy arms in the treatment of relapsed follicular lymphoma (REFRACT): study protocol for a multi-centre, open-label, randomised, phase II platform trial.
Graham McIlroy, Siân Lax, Charlotte Gaskell...
https://pubmed.ncbi.nlm.nih.gov/38528445