Actively Recruiting
Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy
Led by University of Birmingham · Updated on 2026-05-05
284
Participants Needed
25
Research Sites
429 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
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.
CONDITIONS
Official Title
Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy confirmed relapsed or refractory CD20 positive, grade 1-3a follicular lymphoma within 3 months of trial entry
- Age 18 years or older
- Advanced disease requiring treatment as judged by treating physician
- Suitable for standard available therapy at investigator's discretion
- Prior therapy with at least one line of immunochemotherapy; prior radiotherapy or rituximab monotherapy allowed if immunochemotherapy also received
- Disease measurable by PET-CT with at least one node >1.5 cm or extranodal lesion >1 cm
- ECOG performance status 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 with marrow infiltration/splenomegaly), liver enzymes ≤ 3 x ULN, bilirubin ≤ 2 x ULN unless Gilbert's syndrome, creatinine clearance ≥ 50 mL/min, coagulation within limits unless anticoagulated, and normal heart function
- Able to provide written informed consent
- Women of childbearing potential and their partners must use effective contraception
You will not qualify if you...
- Transformation to high grade lymphoma within 1 year, including grade 3b follicular lymphoma
- Non-FDG avid disease
- Prior allogenic stem cell or solid organ transplant
- Previous treatment with lenalidomide
- CAR-T therapy within 100 days before starting trial treatment
- Planned stem cell transplant or maintenance therapy within 24 weeks of starting treatment
- Planned platinum-containing immunochemotherapy
- Known HIV infection or uncontrolled hepatitis C
- Hepatitis B surface antigen positive or detectable viral DNA; positive core antibody without viral DNA is allowed
- Other malignancy within 2 years except certain early or non-invasive cancers
- Active systemic infection requiring treatment
- Central nervous system involvement with lymphoma
- Allergy or anaphylaxis to anti-CD20 monoclonal antibody therapy
- Hypersensitivity to any experimental or control study drugs
- Serious medical or psychiatric illness likely to interfere with study participation
- Recent cancer treatment within 4 weeks or systemic steroid treatment above specified doses within 7 days
- Unwillingness to use contraception during and after treatment as specified
- Pregnant or breastfeeding women
- Prior treatment with the experimental therapy under investigation
- Major surgery within 30 days before starting treatment
- Severe heart conditions related to specific chemotherapy regimens
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
T
Trial Coordinator
CONTACT
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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