A data and sample collection study for patients with diffuse large B-cell lymphoma

ISRCTN ISRCTN17717066
DOI https://doi.org/10.1186/ISRCTN17717066
IRAS number 270224
Secondary identifying numbers CPMS 48169, IRAS 270224
Submission date
09/07/2021
Registration date
16/08/2021
Last edited
13/03/2023
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
Diffuse large B-cell lymphoma (DLBCL) is a cancer of the lymphatic system where B-cells (a type of white blood cell) grow uncontrollably. The standard treatment for DLBCL is a combination of chemotherapy and immunotherapy, referred to as chemo-immunotherapy. Currently, the best results in the treatment of DLBCL is with a chemo-immunotherapy combination called R-CHOP.
R-CHOP is not suitable for all patients with DLBCL as one of the drugs can damage the heart. If patients have heart disease or other problems, it may be too risky for them to receive full dose R-CHOP. There have also been some research studies showing that R-CHOP may also be unsuitable for people over the age of 80 years. If this is the case, many patients either receive a reduced dose called mini R-CHOP, or receive one of two alternatives, R-GCVP or R-CEOP. Additionally, some patients are treated with R-CHOP but do not respond or may respond initially before relapsing. For these patients, treatment is not standardised and practice varies between hospitals.
This study aims to bring together data about the diagnosis, management and outcomes of patients with DLBCL who are unsuitable for standard treatment because they are not well enough to tolerate the side effects or because they have not responded or relapsed following initial treatment. In doing so, it will improve research into DLBCL leading to a better understanding of this condition.

Who can participate?
Patients aged 16 years and over who have previously untreated DLBCL (new disease that is unsuitable for full-dose R-CHOP or relapsed/refractory disease, i.e. that has come back or does not respond to treatment)

What does the study involve?
Data will be captured by participating centres at the start of the study, at each cycle of treatment, at the post-treatment visit and for a further 12 months during follow up. Optional consent will be sought from patients in order to collect blood and tissue samples for future research.

What are the possible benefits and risks of participating?
Participants will be informed that they are unlikely to benefit directly. The study won't involve any extra visits or procedures outside of the standard of care treatment other than optional sample collection. This will involve the minor discomfort associated with blood sampling.

Where is the study run from?
The Clatterbridge Cancer Centre NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
May 2019 to September 2024

Who is funding the study?
F. Hoffmann-La Roche Ltd (Switzerland)

Who is the main contact?
Dr Hannah Short
apollo@liverpool.ac.uk

Plain English summary under review with external organization

Contact information

Dr Hannah Short
Scientific

Trial Manager
Liverpool Clinical Trials Centre
The University of Liverpool
Liverpool
L69 3BX
United Kingdom

+44 (0)151 794 9768
apollo@liverpool.ac.uk

Study information

Study designObservational; Design type: Cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleA prospective ‘real-world data’ registry and sample collection study for patients with diffuse large B-cell lymphoma
Study acronymAPOLLO+
Study hypothesisThis is a descriptive study and there is no a priori hypothesis to be tested. It is anticipated that the results of this study will be used for hypothesis generation to be tested in future studies. Addressing these areas of unmet need is critical to inform future therapeutic strategies and trials.
Ethics approval(s)Approved 14/04/2021, Wales Research Ethics Committee 5 REC (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF 11 9AB, UK; +44 (0)7787 371748, +44 (0)2920 230457; Wales.REC5@wales.nhs.uk), REC ref: 21/WA/0025
ConditionDiffuse large B-cell lymphoma
InterventionAPOLLO+ is designed to collect prospective demographic and clinical data from patients with DLBCL falling into one of two cohorts:
1. Patients ineligible for first-line treatment with R-CHOP (a maximum of 1,283 patients)
2. Patients with relapsed/refractory DLBCL (256-385 patients)

A maximum of 1,668 patients will be recruited across 81 sites in the UK.

Sample size calculations are based on the incidence and prevalence rates of DLBCL. Considering that the prevalence of DLBCL is approximately 8.5 per 100,000 patients15 across the UK and that the patients will be sampled across ~81 treatment centres in the UK population, it can be inferred that approximately 770 -1,283 patients will be available for recruitment into cohort A and 256 -385 patients will be available for recruitment into cohort B during study recruitment period (18 months).

After obtaining written, informed consent, data will be captured by participating centres at baseline, at each cycle of treatment, at the post-treatment visit and for a further 12 months during follow up. This data will be entered directly into the study RedCAP database by participating sites. The schedule for data entry is flexible (at least every 6 months).

Optional consent will be sought from patients in order to collect blood and tissue samples for biobanking to promote future translational research. This consent will be monitored at the Liverpool Clinical Trials Centre where NHS numbers and patient names will be stored securely, separate to other study data.

Further optional consent will be sought for enrolment into the Quality of Life sub-study. If patients consent, they will be asked to complete an EQ-5D-5L Quality of Life Questionnaire at baseline and post-treatment in order to assess the impact of treatments on quality of life. Only patients registered prior to treatment start will be eligible for the sub-study.

Analysis will be carried out by the study statistician at the Liverpool Clinical Trials Centre.
Intervention typeOther
Primary outcome measureProgression-free survival at 12 months (PFS12), defined as disease progression or recurrence, or death from any cause (defined as days from the date of cohort assignment to event) occurring within 12 months (from the date of cohort assignment) as assessed by the investigator using the revised Lugano response criteria for malignant lymphoma (2016)
Secondary outcome measures1. Time to next treatment measured as days from the start date of initial treatment to the start day of the next treatment
2. Demographic and clinical characteristics (e.g. age, sex, ethnicity, duration of disease, comorbidities, disease activity/severity, blood results) collected at baseline
3. Investigator-assessed Interim (post-cycle 4) and end of treatment responses as assessed by the investigator using the revised Lugano response criteria for malignant lymphoma (2016)
4. Overall survival (OS) measured as the time from recruitment until death by any cause
5. Relapses following treatment as assessed by the investigator using the revised Lugano response criteria for malignant lymphoma (2016) every 6 months after the end of treatment
6. Treatment pathways, including chemo-immunotherapy, concomitant treatments (including radiotherapy) and salvage therapy, recorded at treatment start and during treatment (cycles 1 to 8)
7. Quality of life measured using the EQ-5D-5L patient-completed questionnaire at baseline and end of treatment
8. Co-morbidity/frailty assessments using echocardiography or nuclear medicine examination (MUGA) pre- and post-treatment
Overall study start date30/05/2019
Overall study end date30/09/2024
Reason abandoned (if study stopped)Lack of funding/sponsorship

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 1668; UK Sample Size: 1668
Total final enrolment0
Participant inclusion criteria1. Males and female subjects ≥16 years of age at the time of enrolment
2. Ability to understand and sign written informed consent
3. Histologically proven diffuse large B cell non-Hodgkin’s lymphoma (DLBCL) according to current World Health Organisation 2016 guidelines that fall into one of two cohorts that will be independently evaluated/reported:
3.1. DLBCL patients with de novo disease unfit for full dose R-CHOP
OR
3.2. DLBCL patients with relapsed/refractory disease
4. Patients fulfilling the above criteria who are on other trials/studies are eligible for recruitment
Participant exclusion criteriaPatients commencing index treatments >6 months prior to trial enrolment (Cohorts A or B). In other words, patients can be retrospectively entered (for Cohorts A or B). This exclusion does not apply to prior therapies before the index treatment event for Cohort B.
Recruitment start date01/06/2022
Recruitment end date31/03/2023

Locations

Countries of recruitment

  • England
  • Scotland
  • United Kingdom
  • Wales

Study participating centres

The Clatterbridge Cancer Centre
Clatterbridge Road
Bebington
CH63 4JY
United Kingdom
Arrowe Park Hospital
Wirral University Teaching Hospital NHS Foundation Trust
Arrowe Park Road
Upton
CH49 5PE
United Kingdom
Airedale General Hospital
Airedale NHS Foundation Trust
Skipton Road
Steeton
BD20 6TD
United Kingdom
Bradford Royal Infirmary
Bradford Teaching Hospitals NHS Foundation Trust
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
John Radcliffe Hospital
Oxford University Hospitals NHS Foundation Trust
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Countess of Chester Hospital
Countess of Chester Health Park
Liverpool Road
Chester
CH2 1UL
United Kingdom
Derriford Hospital
University Hospitals Plymouth NHS Trust
Derriford Road
Derriford
Plymouth
PL6 8DH
United Kingdom
NHS Forth Valley
33 Spittal Street
Stirling
FK8 1DX
United Kingdom
Colchester Dist General Hospital
East Suffolk and North Essex NHS Foundation Trust
Turner Road
Colchester
CO4 5JL
United Kingdom
Ysbyty Gwynedd
Betsi Cadwaladr University LHB
Executive Offices
Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom
Gartnavel Royal Hospital
NHS Greater Glasgow and Clyde
J B Russell House
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
Lincoln County Hospital
United Lincolnshire Hospitals NHS Trust
Greetwell Road
Lincoln
LN2 5QY
United Kingdom
St Thomas' Hospital
Guy's and St Thomas' NHS Foundation Trust
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Colchester Dist General Hospital
East Suffolk and North Essex NHS Foundation Trust
Turner Road
Colchester
CO4 5JL
United Kingdom
Watford General Hospital
West Hertfordshire Hospitals Nhs Trust
Trust Offices
Vicarage Road
Watford
WD18 0HB
United Kingdom
Kent & Canterbury Hospital
East Kent Hospitals University NHS Foundation Trust
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom
Kettering General Hospital
Rothwell Road
Kettering
NN16 8 UZ
United Kingdom
Leicester Royal Infirmary
University Hospitals of Leicester NHS Trust
Infirmary Square
Leicester
LE1 5WW
United Kingdom
University Hospital Lewisham
Lewisham and Greenwich NHS Trust
Lewisham High Street
London
SE13 6LH
United Kingdom
Milton Keynes University Hospital
Standing Way
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Musgrove Park Hospital
Taunton and Somerset NHS Foundation Trust
Taunton
TA1 5DA
United Kingdom
St Cadoc's Hospital
Aneurin Bevan University LHB Headquarters
Lodge Road
Caerleon
Newport
NP18 3XQ
United Kingdom
Norfolk and Norwich University Hospital
Norfolk and Norwich University Hospitals Nhs Foundation Trust
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom
Northwick Park Hospital
London North West University Healthcare NHS Trust
Watford Road
Harrow
HA1 3UJ
United Kingdom
Queens Medical Centre
Nottingham University Hospitals NHS Trust
Trust Headquarters
Derby Road
Nottingham
NG7 2 UH
United Kingdom
Hillingdon Hospital
The Hillingdon Hospitals NHS Foundation Trust
Pield Heath Road
Uxbridge
UB8 3NN
United Kingdom
Queen Alexandra Hospital
Portsmouth Hospitals NHS Trust
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
Queen Elizabeth Hospital
The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
Gayton Road
King's Lynn
PE30 4ET
United Kingdom
NHS Highland
Reay House
17 Old Edinburgh Road
Inverness
IV2 3HG
United Kingdom
Royal Sussex County Hospital
Brighton and Sussex University Hospitals NHS Trust
Eastern Road
Brighton
BN2 5BE
United Kingdom
Amersham Hospital
Buckinghamshire Healthcare NHS Trust
Whielden Street
Amersham
HP7 0JD
United Kingdom
Cardiff & Vale University LHB
Woodland House
Maes-Y-Coed Road
Cardiff
CF14 4HH
United Kingdom
Royal Derby Hospital
University Hospitals of Derby and Burton NHS Foundation Trust
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Russells Hall Hospital
The Dudley Group NHS Foundation Trust
Pensnett Road
Dudley
DY1 2 HQ
United Kingdom
St Helier Hospital
Epsom and St Helier University Hospitals NHS Trust
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
The Royal London Hospital
Barts Health NHS Trust
80 Newark Street
London
E1 2ES
United Kingdom
Gartnavel Royal Hospital
NHS Greater Glasgow and Clyde
J B Russell House
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
St. James's University Hospital
Leeds Teaching Hospitals NHS Trust
Beckett Street
Leeds
LS9 7TF
United Kingdom
Royal Liverpool University Hospital
Liverpool University Hospitals NHS Foundation Trust
Prescot Street
Liverpool
L7 8XP
United Kingdom
Manchester University NHS Foundation Trust
Cobbett House
Oxford Road
Manchester
M13 9WL
United Kingdom
Southmead Hospital
North Bristol NHS Trust
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
Royal Cornwall Hospital
Royal Cornwall Hospitals NHS Trust
Treliske
Truro
TR1 3LJ
United Kingdom
Salford Royal
Salford Royal NHS Foundation Trust
Stott Lane
Salford
M6 8HD
United Kingdom
Northern General Hospital
Sheffield Teaching Hospitals NHS Foundation Trust
Herries Road
Sheffield
S5 7AU
United Kingdom
Warwick Hospital
South Warwickshire NHS Foundation Trust
Lakin Road
Warwick
CV34 5BW
United Kingdom
Southend University Hospital
Prittlewell Chase
Westcliff-On-Sea
SS0 0RY
United Kingdom
St George's Hospital
St George's University Hospitals NHS Foundation Trust
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Whiston Hospital
St Helens and Knowsley Teaching Hospitals NHS Trust
Warrington Road
Prescot
L35 5DR
United Kingdom
Torbay Hospital
Torbay and South Devon NHS Foundation Trust
Newton Road
Torquay
TQ2 7 AA
United Kingdom
Royal Stoke University Hospital
University Hospitals of North Midlands NHS Trust
Newcastle Road
Stoke-On-Trent
ST4 6QG
United Kingdom
Southampton General Hospital
University Hospital Southampton NHS Foundation Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom
York Hospital
York Teaching Hospital NHS Foundation Trust
Wigginton Road
York
YO31 8HE
United Kingdom
Freeman Hospital
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Victoria Hospital
Blackpool Teaching Hospitals NHS Foundation Trust
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom
Christie Hospital
The Christie NHS Foundation Trust
550 Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
City Hospital
Sandwell and West Birmingham Hospitals NHS Trust
Dudley Road
Birmingham
B18 7QH
United Kingdom
The Maidstone Hospital
Maidstone and Tunbridge Wells NHS Trust
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom

Sponsor information

Clatterbridge Cancer Centre NHS Foundation Trust
Hospital/treatment centre

c/o Maria Maguire
Clatterbridge Road
Bebington
Wirral
CH63 4JY
England
United Kingdom

+44 (0)1515565321
maria.maguire2@nhs.net
http://www.clatterbridgecc.nhs.uk/
ROR logo https://ror.org/05gcq4j10

Funders

Funder type

Industry

F. Hoffmann-La Roche; Grant Codes: ML41801
Private sector organisation / For-profit companies (industry)
Alternative name(s)
Hoffman-La Roche, F. Hoffmann-La Roche Ltd.
Location
Switzerland

Results and Publications

Intention to publish date30/09/2025
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal. Additional files aren’t currently available.
IPD sharing planThe data-sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

13/03/2023: The study was stopped on 23/01/2023 before any participants had been enrolled.
11/03/2022: The recruitment start date has been changed from 01/02/2022 to 01/06/2022.
25/11/2021: The recruitment start date has been changed from 31/10/2021 to 01/02/2022.
09/07/2021: Trial's existence confirmed by the NIHR.

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