How treatments affect people recently diagnosed with follicular lymphoma. A study over time
| ISRCTN | ISRCTN80351925 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80351925 |
| IRAS number | 221775 |
| Secondary identifying numbers | CPMS 66722 |
- Submission date
- 19/09/2025
- Registration date
- 21/10/2025
- Last edited
- 21/10/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
PETReA Plus will enrol all newly diagnosed follicular lymphoma patients receiving any first treatment as part of their normal care. This is an observational study which will collect data during the clinical care of the study participants. Except for Quality of Life (QOL) questionnaires provided as Patient Reported Outcome Measures (PROMs), no extra tests or assessments will be carried out over and above standard care. The study aims to collect all the required information during the participants' planned clinic visits, where available.
Who can participate?
Adult patients aged 18 years or older with Grade 1, 2, 3A or 3B follicular lymphoma (FL), or de novo transformed FL, who have had a diagnostic biopsy within the last 6 months, are planned for any first-line treatment or initial watch and wait, and can provide written informed consent.
What does the study involve?
Routinely collected information can be taken from the participant’s medical notes into the case report form once the participant has consented. Data will be collected from the participants before treatment starts, at the end of treatment and during a follow-up period (6 months +/- 2 months). There are no investigational treatments, extra risks or benefits to taking part in the study. Doctors are asked to offer participation in the PETReA Plus study to all patients who are not in the PETReA trial for as long as this remains open and thereafter to all newly diagnosed FL patients, including those participating in another CTIMP/non-CTIMP trial at local PI discretion, as long as this doesn't impact the PETReA Plus study or eligibility/conduct of the other trial. Data from the PETReA Plus study will be collected along with data from the PETReA trial to produce a combined dataset of up to 1500 participants that could provide more information on people with high tumour burden symptomatic FL who normally have a poor chance of survival.
If willing, PETReA Plus participants will also be invited to consent to share their data with the Follicular Lymphoma Foundation Registry, for an international, observational study in follicular lymphoma, which will collect data from previously treated and untreated patients to improve how quickly new treatments are made available and to standardise treatment and care for patients across all clinics and hospitals. If willing, participants can also consent at a later date for the future collection of their routinely collected tumour tissue for future ethically approved research. These would be stored at the UK Blood Cancer Biobank.
What are the possible benefits and risks of participating?
There are no benefits/risks to the participant if they take part in the study.
Where is the study run from?
University of Liverpool, UK.
When is the study starting and how long is it expected to run for?
September 2024 to October 2029. The study is expected to begin enrolling participants in November 2025 and will conclude enrollment in February 2028.
Who is funding the study?
1. The Follicular Lymphoma Foundation
2. Blood Cancer UK
3. The Joyce & Norman Freed Charitable Trust
Who is the main contact?
PETReA Plus Trial Manager, petreaplus@liverpool.ac.uk
Contact information
Public, Scientific
PETReA Plus Trial Manager, LCTC, University of Liverpool, Block C Waterhouse Building, 3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
| Phone | +44 (0)151 795 5289 |
|---|---|
| petreaplus@liverpool.ac.uk |
Principal Investigator
Chief Investigator, The University of Manchester, Cancer Research UK Manchester Institute, Wilmslow Road
Manchester
M20 4BX
United Kingdom
 ORCID ID |
0000-0002-3294-1548 |
|---|---|
| kim.linton@manchester.ac.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Prospective observational study of treatment & outcomes for patients with newly diagnosed follicular lymphoma |
| Study acronym | PETReA Plus |
| Study objectives | Primary Objective 1) To report progression-free survival for FL by stage, grade (1-3A; 3B; transformed), tumour burden (low/high by GELF criteria) and first-line treatment. Secondary Objective(s) 2) To report other clinical outcomes (treatment response rates by CT or PET-CT, duration of response, time to next treatment and overall survival) for FL by stage, grade (1-3A; 3B; transformed), tumour burden (low/high by GELF criteria) and first-line treatment 3) To describe first-line treatments for FL and associated patient characteristics (age, ECOG, CIRS-G score, etc) and disease characteristics (stage, grade, tumour burden, etc.) 4) To describe second line treatments for relapsed FL as well as associated clinical outcomes(response rates, duration of response, progression free survival, time to next treatment and overall survival), patient and disease characteristics of early treatment failure, defined as PR/SD/PD as best response to first line therapy (+/- consolidation or maintenance) or disease progression within 24 months (POD24) of initiating any first line treatment) 5) To report rates of initiation and completion of maintenance anti-CD20 antibody therapy, reasons for discontinuation and clinical outcomes by number of maintenance cycles 6) To describe the use of PET for initial staging and response assessment in standard care 7) To report the rate of high-grade transformation after first-line treatment in PET-staged FL, as well as clinical outcomes, patient and disease characteristics 8) To report serious adverse events and grade 3 adverse events related to clinical treatment (recorded but not reported in real time) 9) To report the patient experience using quality of life questionnaires 10) To report reasons for ineligibility for the main PETReA trial whilst this remains open to recruitment |
| Ethics approval(s) |
Approved 30/04/2025, East of England- Cambridge East Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; CambridgeEastREC@hra.nhs.uk), ref: 25/EE/0092 |
| Health condition(s) or problem(s) studied | Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue |
| Intervention | PETREA Plus will enrol all newly diagnosed follicular lymphoma patients receiving any first treatment as part of their normal care. This is an observational study which will collect data during the clinical care of the study participants. Except for Quality of Life (QOL) questionnaires provided as Patient Reported Outcome Measures (PROMs), no extra tests or assessments will be carried out over and above standard care. The study aims to collect all the required information during the participants' planned clinic visits, where available. Routinely collected information can be taken from the participant's medical notes into the case report form once the participant has consented. Data will be collected from the participants before treatment starts, at the end of treatment and during a follow-up period (6 months +/- 2 months). There are no investigational treatments, extra risks or benefits to taking part in the study. Doctors are asked to offer participation in the PETREA Plus study to all patients who are not in the PETREA trial for as long as this remains open and thereafter to all newly diagnosed FL patients, including those participating in another CTIMP/non-CTIMP trial at local PI discretion, as long as this doesn't impact the PETREA Plus study or eligibility/conduct of the other trial. Data from the PETREA Plus study will be collected along with data from the PETREA trial, to produce a combined dataset of up to 1500 participants that could provide more information on people with high tumour burden symptomatic FL who normally have a poor chance of survival. If willing, PETREA Plus participants will also be invited to consent to share their data with the Follicular Lymphoma Foundation Registry, for an international, observational study in follicular lymphoma, which will collect data from previously treated and untreated patients to improve how quickly new treatments are made available and to standardise treatment and care for patients across all clinics and hospitals. If willing, participants can also consent at a later date for the future collection of their routinely collected tumour tissue for future ethically approved research. These would be stored at the UK Blood Cancer Biobank. |
| Intervention type | Other |
| Primary outcome measure | Progression-free survival, measured using data collected from the patients’ medical records, will be assessed from patient consent before the start of first-line active treatment to follow-up every 6 months until death or study end (patients who do not die will be censored at the date they were last known alive) |
| Secondary outcome measures | 1. Anatomical response will be measured using CT scan-reported results collected from patient medical records, post-treatment. 2. Metabolic response will be measured using PET CT scan reported results (if performed) collected from patient's medical records, post-treatment. 3. Duration of response for each treatment received will be measured using data collected from patient medical records, from the start of active treatment to follow-up every 6 months until documentation of relapse, progression, high-grade transformation, start date of next line therapy, death or study end (patients who do not die will be censored at the date they were last known alive). 4. Progression-free survival will be measured using data collected from patient medical records, from patient consent prior to start of second-line active treatment to follow-up every 6 months until death or study end (patients who do not die will be censored at the date they were last known alive). 5. Time to next treatment will be measured using data collected from patient medical records, from day 1 of the last cycle of systemic induction therapy (or maintenance therapy if given), or last dose of radiotherapy to next treatment or death (patients who do not die will be censored at the date they were last known alive). 6. Time to next chemotherapy will be measured using data collected from patient medical records, from day 1 of the last cycle of systemic induction therapy (or maintenance therapy if given), or last dose of radiotherapy to next treatment or death (patients who do not die will be censored at the date they were last known alive). 7. Overall survival will be measured using data collected from patient medical records, from the date of diagnosis to the date of death from any cause (patients who do not die will be censored at the date they were last known alive). 8. First-line induction treatment will be measured using data collected from patient medical records at the start of active treatment. 9. Maintenance treatment will be measured using data collected from patient medical records, post-induction and during maintenance. 10. Use of PET-CT will be measured using data collected from patient medical records, at baseline staging and end of induction, consolidation, and maintenance treatment response assessment. 11. High-grade transformation will be measured using CT scan-reported results collected from patient medical records, from baseline data collection to follow-up every 6 months until study end. 12. Serious adverse events and grade 3 related adverse events will be measured using data collected from patient medical records, from the start of treatment to 30 days post-treatment. 13. Quality of life (QoL) will be measured using patient-completed QoL questionnaires (FACT-Lym, EQ-5D-5L, QLQ-C30), at start of treatment, post-treatment, and follow-up every 6 months until study end. 14. Reasons for consent decline and screen failure for PETReA trial will be measured using data collected from patients (if willing) to indicate a reason, during screening/consent discussion. |
| Overall study start date | 01/09/2024 |
| Completion date | 31/10/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 500; UK Sample Size: 500 |
| Key inclusion criteria | 1. > = 18 years of age at the time of consent 2. Grade 1, 2, 3A or 3B FL, or FL with histologically confirmed/clinically suspected high-grade transformation at initial presentation (de novo transformed FL) 3. Diagnostic biopsy performed within the last 6 months prior to study consent 4. Any first-line treatment planned (radiotherapy, immunotherapy, immunochemotherapy) or patients planned for initial watch and wait (these patients will have baseline data collection initially and further data will be collected if treatment (including rituximab monotherapy) starts within the study period. For patients that have already started watch and wait or treatment they can be enrolled for retrospective data collection as long as they have only received 1-2 cycles of treatment or are within one month of initiating watch and wait/treatment). 5. Able to provide written informed consent |
| Key exclusion criteria | 1. Patients enrolled on the PETReA trial. Patients enrolled on another IMP/intervention trial may be included in PETReA Plus as long as they adhere to the inclusion/exclusion of the trial they are enrolled on. 2. Any prior treatment for follicular lymphoma or transformed follicular lymphoma (except steroids) 3. Pregnant or lactating females 4. Any serious medical condition or other reason that would prevent the subject from participating in the study in the opinion of the treating physician or investigator. |
| Date of first enrolment | 01/11/2025 |
| Date of final enrolment | 29/02/2028 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Tremona Road
Southampton
SO16 6YD
United Kingdom
Arrowe Park Road
Wirral
CH49 5PE
United Kingdom
Wirral
CH63 4JY
United Kingdom
Derriford
Plymouth
PL6 8DH
United Kingdom
Canterbury
CT1 3NG
United Kingdom
C Floor, Huntsmnan Building
Herries Road
Sheffield
S5 7AU
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Croydon
CR7 7YE
United Kingdom
The Castle Business Park
Stirling
FK9 4SW
United Kingdom
Poole
BH15 2JB
United Kingdom
Taunton
TA1 5DA
United Kingdom
Leicester
LE1 5WW
United Kingdom
London
NW1 2PG
United Kingdom
London
E1 2ES
United Kingdom
Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom
Turner Road
Colchester
CO4 5JL
United Kingdom
Withington
Manchester
M20 4BX
United Kingdom
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom
Glasgow
G12 0XH
United Kingdom
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Belfast
BT9 7AB
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
B71 4HJ
United Kingdom
Standing Way
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Salford
M6 8HD
United Kingdom
Truro
TR1 3LJ
United Kingdom
Dudley
DY1 2HQ
United Kingdom
Burton-on-trent
DE13 0RB
United Kingdom
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom
Huntingdon
PE29 6NT
United Kingdom
Oldham
OL1 2JH
United Kingdom
Boston
PE21 9QS
United Kingdom
Lincoln
LN2 5QY
United Kingdom
Sutton Coldfield
B75 7RR
United Kingdom
Carmarthen
SA31 3BB
United Kingdom
Isleworth
TW7 6AF
United Kingdom
Cosham
Portsmouth
PO6 3LY
United Kingdom
Nottingham
NG5 1PB
United Kingdom
Carshalton, Surrey
SM5 1AA
United Kingdom
Enfield
EN2 8JL
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Grantham
NG31 8DG
United Kingdom
Sponsor information
Hospital/treatment centre
University of Liverpool, Clinical Directorate
Room 2.10, Thompson Yates Building, The Quadrangle, Brownlow Hill
Liverpool
L3 5RB
England
United Kingdom
| Phone | +44 (0)1517951780 |
|---|---|
| sponsor@liverpool.ac.uk | |
| Website | https://www.liverpool.ac.uk/ |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
Charity
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 30/10/2030 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal and conference setting. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
13/10/2025: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).
