SWAG SSG Haematology and Lymphoma Meeting Clinical Research Network West of England SWAG SSG Haematology and Lymphoma Meeting Wednesday 2nd November 2016

Clinical Research Network & Cancer Services West ofEngland SWAG - Somerset Wiltsire Avon & Gloucestershire South West Children’s Cancer & Leukaemia Research Network

NIHR CRN – what does it do? Infrastructure that allows high-quality clinical research to take place in the NHS Help researchers to set up clinical studies quickly and effectively Support the life-sciences industry to deliver their research programmes in the NHS Provide health professionals with research training Work with patients to ensure their needs are at the very centre of all research activity.

NIHR CRN High Level Objectives Increase number of participants into NIHR CRN portfolio studies Target 650,000 in England pa Target 22,000 in West of England pa Increase the number of studies that deliver to time and target Objective 80% Increase number of commercial studies delivered through network Reduce NHS study set up times Reduce time taken to recruit first participant

Local Clinical Research Networks Translation of national objectives for clinical research Oversight of research activity within the geography of CRN - West of England in terms of: Portfolio Balance, new studies, feasibility, set up, industry trials Performance Support, network wide solutions, targets People Patient involvement, staff skill mix & flexibility, training, resources

30 Clinical Specialties Ageing Anaesthetics & pain Cancer Cardiovascular Children Critical Care Dementia & Neurodegenerative Dermatology Diabetes ENT Gastroenterology Genetics Haematology Health Services Hepatology Infectious Diseases Injuries & Emergencies Mental Health Metabolic & Endocrine Musculoskeletal Neurological Opthalmology Oral & Dental Primary Care Public Health Renal Reproductive Health Respiratory Stroke Surgery

Including lymphoma

Local CRN sub specialty leads NCRI Clinical Studies Groups NIHR CRN cancer leadership

National Clinical Studies Groups PPI Psychosocial & Survivorship Imaging Adv. panel Breast Cancer CSG Brain Tumours CSG Lung Cancer CSG Palliative & Supportive Care Head & Neck CSG Biomarkers Adv. panel Upper GI Cancer CSG Consumer Liaison Group Sarcoma CSG PPI Colorectal Cancer CSG Melanoma CSG Kidney Cancer CSG Primary Care Lymphoma CSG Bladder Cancer CSG Screening, Prevention & Early Diagnosis Haematol. CSG Testis Cancer CSG Prostate Cancer CSG Gynae Cancer CSG Children’s Cancer & Leukaemia Teenage & Young Adult CTRad (Radiotherapy)

Cancer sub specialty lead role Communicate and collaborate with clinical colleagues across the network re the portfolio of studies in their sub specialty Action plan in place to increase access to research Mapping portfolio across the network Shared portfolio of studies Improve referral pathways for research Encourage more referral for research Consider economies of scale for rare disease studies Network wide planning for EOIs Support and encourage teams to meet study targets

NIHR CRN Objectives for cancer Recruit 20% of cancer incidence West of England 1,909 Recruit 7.5% of cancer incidence into interventional studies 716 Include challenging studies Cancer surgery – 4 recruits per 100,000 population Radiotherapy – 6 recruits per 100,000 population Rare cancers (<6 per 100,000) – 12 recruits per 100,000 population Children & young people – 3 per 100,000 population Teenagers & young adults – record number of 16-25 year olds approached and/or participating in research

% Recruitment of cancer incidence to interventional studies by Local Clinical Research Network 2016-17

% Recruitment to haematological cancer studies by LCRN 2016-17 to date

SWAG study recruitment 2016-17 to date Lymphoma Haematological cancer

Haematology Project Title Project type Primary Clinical Studies Group BRAG Open studies Black Study not reported recruitment or study has not recruited Red % Recruitment is more than 30 behind % time elapsed, i.e. Difference < -30 Amber % Recruitment is less than 30 behind % elapsed time but more than 0 behind % elapsed time, i.e. -30 < Difference < 0 Green % Recruitment is equal to or greater than % elapsed time, i.e. Difference >= 0 Grey Unable to calculate RAG due to record missing at least one data point Haematology Project Title Project type Primary Clinical Studies Group Project design Site parent organisation Principal Investigator BRAG rating Project site date open to recruitment Project site planned recruitment end date Recruited (total) Project site target participants AML 19 Non-commercial portfolio Haematological oncology Interventional Gloucestershire Hospitals NHS Foundation Trust Rye, Dr Adam 25.02% 06/01/2016 04/06/2021 10 25 University Hospitals Bristol NHS Foundation Trust Mehta, Dr Priyanka 9.30% 03/12/2015 01/01/2021 13 48 AML18 Non-commercial portfolio Haematological oncology Interventional Gloucestershire Hospitals NHS Foundation Trust Rye, Dr Adam 58.29% 21/09/2015 20/10/2020 8 10 Great Western Hospitals NHS Foundation Trust Sternberg, Dr Alex -20.34% 23/10/2015 3 University Hospitals Bristol NHS Foundation Trust Mehta, Dr Priyanka 18.61% 10/02/2015 31/08/2019 18 32 CARDAMON Non-commercial portfolio Haematological oncology Interventional Royal United Hospitals Bath NHS Foundation Trust Moore, Dr Sally 40.41% 18/05/2016 11/01/2021 3 6 ELASTIC (TAP) Non-commercial portfolio Haematological oncology Interventional Great Western Hospitals NHS Foundation Trust Sternberg, Dr Alex -71.70% 23/03/2015 30/09/2016 1 3 FIGARO Non-commercial portfolio Haematological oncology Interventional University Hospitals Bristol NHS Foundation Trust Protheroe, Dr Rachel -11.21% 02/05/2014 31/10/2017 6 10

Project Title Project type Primary Clinical Studies Group Project design Site parent organisation Principal Investigator BRAG rating Project site date open to recruitment Project site planned recruitment end date Recruited (total) Project site target participants FLAIR: Front-Line therapy in CLL: Assessment of Ibrutinib + Rituximab Non-commercial portfolio Haematological oncology Interventional Gloucestershire Hospitals NHS Foundation Trust Frewin, Dr Rebecca 21.11% 29/01/2016 31/08/2018 3 6 Great Western Hospitals NHS Foundation Trust Blesing, Dr Norbert -22.07% 06/07/2015 20/08/2018 1 5 North Bristol NHS Trust Otton, Dr Sophie 127.92% 29/01/2015 15/10/2018 7 4 University Hospitals Bristol NHS Foundation Trust Lowry, Lisa -36.85% 12/02/2014 30/06/2018 16 LI-1 Non-commercial portfolio Haematological oncology Interventional Gloucestershire Hospitals NHS Foundation Trust Rye, Dr Adam -57.55% 08/05/2013 07/11/2016 5 12 University Hospitals Bristol NHS Foundation Trust Mehta, Dr Priyanka -12.07% 23/03/2012 01/12/2018 17 30 MAJIC Non-commercial portfolio Haematological oncology Interventional Gloucestershire Hospitals NHS Foundation Trust Frewin, Dr Rebecca -50.57% 28/03/2013 15/08/2015 5

Project Title Project type Primary Clinical Studies Group Project design Site parent organisation Principal Investigator BRAG rating Project site date open to recruitment Project site planned recruitment end date Recruited (total) Project site target participants MDSBio Non-commercial portfolio Haematological oncology Observational Gloucestershire Hospitals NHS Foundation Trust Lush, Dr Richard 301.31% 23/07/2009 28/02/2017 127 32 Great Western Hospitals NHS Foundation Trust Sternberg, Dr Alex 1872.42% 14/02/2007 24/06/2021 291 15 North Bristol NHS Trust Whiteway, Dr Alastair 1.56% 09/11/2008 117 120 Royal United Hospitals Bath NHS Foundation Trust Wexler, Dr Sarah 92.13% 07/01/2013 92 50 University Hospitals Bristol NHS Foundation Trust Mehta, Dr Priyanka 947.33% 25/07/2012 104 10 MUK8 Non-commercial portfolio Haematological oncology Interventional University Hospitals Bristol NHS Foundation Trust Bird, Dr Jenny -22.01% 18/02/2016 01/06/2018 1 12 MyeChild 01 Non-commercial portfolio Haematological oncology Interventional,Observational University Hospitals Bristol NHS Foundation Trust Tunstall, Dr Oliver -4.65% 22/07/2016 30/04/2022 30 OPTIMAL: Optimising Renal outcome in Myeloma renal failure Non-commercial portfolio Haematological oncology Interventional Great Western Hospitals NHS Foundation Trust Anwer, Dr Saiyed -20.19% 22/10/2015 01/07/2017 2 5 Prospective Study of Second Line Therapy for Acute GVHD (POSTAGE) Non-commercial portfolio Haematological oncology Observational University Hospitals Bristol NHS Foundation Trust Griffin, Dr James 15.36% 09/02/2015 01/10/2018 5 8

Project Title Project type Primary Clinical Studies Group Project design Site parent organisation Principal Investigator BRAG rating Project site date open to recruitment Project site planned recruitment end date Recruited (total) Project site target participants Red cell transfusion and QoL in myelodysplastic syndromes (REDDS) Non-commercial portfolio Haematological oncology Interventional Great Western Hospitals NHS Foundation Trust Sternberg, Dr Alex -57.72% 26/01/2015 30/12/2016 1 3 RIAltO Non-commercial portfolio Haematological oncology Interventional Great Western Hospitals NHS Foundation Trust Blesing, Dr Norbert 57.40% 18/12/2012 31/03/2016 7 4 Royal United Hospitals Bath NHS Foundation Trust Knechtli, Dr Christopher 259.70% 20/02/2012 30/04/2017 2 Weston Area Health NHS Trust Gamare, Rajesh 22.40% 03/10/2012 31/12/2017 TREATT: Trial to EvaluAte Tranexamic acid therapy in Thrombocytopenia Non-commercial portfolio Haematological oncology Interventional University Hospitals Bristol NHS Foundation Trust Mumford, Dr Andrew -5.34% 18/02/2016 30/08/2019 5 35 UK Haplo Non-commercial portfolio Haematological oncology Interventional University Hospitals Bristol NHS Foundation Trust Protheroe, Dr Rachel 52.75% 26/06/2013 31/12/2018 17 15 UKALL 14 Non-commercial portfolio Haematological oncology Interventional Gloucestershire Hospitals NHS Foundation Trust Rye, Dr Adam 303.39% 28/11/2011 30/12/2016 8 2 Royal United Hospitals Bath NHS Foundation Trust Knechtli, Dr Christopher 63.12% 21/06/2011 5 University Hospitals Bristol NHS Foundation Trust Marks, Prof David 67.04% 04/02/2011 01/01/2018 30 20

Haematology continued Project Title Project type Primary Clinical Studies Group Project design Site parent organisation Principal Investigator BRAG rating Project site date open to recruitment Project site planned recruitment end date Recruited (total) Project site target participants UKALL60+ Non-commercial portfolio Haematological oncology Interventional Great Western Hospitals NHS Foundation Trust Blesing, Dr Norbert -117.15% 27/09/2013 28/02/2015 1 WT1 TCR-001 Non-commercial portfolio Haematological oncology Interventional University Hospitals Bristol NHS Foundation Trust Robinson, Dr Stephen -29.74% 27/05/2015 01/01/2018 1 4 WT1TCR -002 Phase I/II study of genemodified WT1 TCR therapy in MDS & AML patient Non-commercial portfolio Haematological oncology Interventional University Hospitals Bristol NHS Foundation Trust Protheroe, Dr Rachel 36.21% 23/06/2016 31/12/2018 1 2

Lymphoma recruitment to time and target Project Title Project type Primary Clinical Studies Group Project design Site parent organisation Principal Investigator BRAG rating Project site date open to recruitment Project site planned recruitment end date Recruited (total) Project site target participants CHEMO-T Non-commercial portfolio Lymphoma Interventional Gloucestershire Hospitals NHS Foundation Trust Benstead, Dr Kim -56.99% 02/01/2014 31/03/2017 3 10 INCA Non-commercial portfolio Lymphoma Interventional Royal United Hospitals Bath NHS Foundation Trust Knechtli, Dr Christopher -50.29% 26/03/2015 01/07/2017 1 5 University Hospitals Bristol NHS Foundation Trust Lowry, Lisa -39.92% 02/09/2015 13/06/2017 4 MCL Biobank Observational Study Non-commercial portfolio Lymphoma Observational Gloucestershire Hospitals NHS Foundation Trust Lush, Dr Richard 15.70% 20/04/2015 30/09/2019 5 10 North Bristol NHS Trust Siddiq, Samreen 29.15% 21/01/2016 1 2 Royal United Hospitals Bath NHS Foundation Trust Wexler, Dr Sarah 19.03% 03/05/2016 3 9 University Hospitals Bristol NHS Foundation Trust Lowry, Lisa -45.70% 26/02/2015 31/10/2017 30 Molecular profiling for lymphoma (MaPLE) Non-commercial portfolio Lymphoma Observational Great Western Hospitals NHS Foundation Trust Blesing, Dr Norbert -21.06% 03/12/2014 02/06/2016 53 50 Royal United Hospitals Bath NHS Foundation Trust Knechtli, Dr Christopher 154.19% 04/12/2014 31/08/2018 41 20

Lymphoma continued Project Title Project type Primary Clinical Studies Group Project design Site parent organisation Principal Investigator BRAG rating Project site date open to recruitment Project site planned recruitment end date Recruited (total) Project site target participants Non-Hodgkin Lymphoma in Young Adults Non-commercial portfolio Lymphoma Observational University Hospitals Bristol NHS Foundation Trust Lowry, Lisa 849.36% 17/12/2015 01/09/2017 9 1 PROCLIPI Non-commercial portfolio Lymphoma Observational Gloucestershire Hospitals NHS Foundation Trust Benstead, Dr Kim -8.65% 10/12/2015 01/06/2020 1 9 University Hospitals Bristol NHS Foundation Trust Dunnill, Dr MGS -16.94% 22/12/2015 31/12/2020 25 ProT4 (Prophylactic Transfer of CD4 Lymphocytes) Non-commercial portfolio Lymphoma Interventional University Hospitals Bristol NHS Foundation Trust Robinson, Dr Stephen 350.68% 26/10/2012 07/11/2016 18 4 NCRN 3245 – Betalutin radioimmunotherapy for treatment of relapsed CD37+NHL . Commercial Target 7. Recruited 6. Open at UHB. Currently suspended.

Recruitment to time and target for Taunton and Yeovil Trial Name Specialty Commercial Study Trust Investigator Name End Date of Recruitment Phase Participant Recruitment Target Recruitment (EDGE) RAG AML 19 Haematological oncology No Taunton Bolam, Dr Simon 01/01/2021 5 3 46 AML18 Mannari, Dr Deepak 20/10/2020 8 14 EBV associated NK/T cell malignancies 17/01/2017 2 -97 FLAIR: Front-Line therapy in CLL: Assessment of Ibrutinib + Rituximab Austen, Dr Belinda 20/08/2018 59 GALACTIC 30/08/2018 6 -21 LI-1 Yeovil 07/11/2016 52 UKALL 14 29/12/2016 4 9 129 CHEMO-T Lymphoma 31/03/2019 1 -38 31/03/2017 12 LEGEND 01/02/2018 -54 MCL Biobank Observational Study 31/10/2017 -23 -24 CANC - 5009 Study of CT-P10 in patients with Low Tumour Burden Follicular Lymphoma Yes 28/02/2018 -22

Studies in set up - Haematology Studies in set up - Lymphoma

Useful links https://www.crn.nihr.ac.uk/ National and local network information including training programmes templates, tools, contacts, videos etc https://odp.nihr.ac.uk/ http:/ Open data platform. Look at performance across whole CRN including all specialty areas /csg.ncri.org.uk/portfolio/portfolio-maps/ View current national portfolio of open, closed and ‘in set up’ cancer studies https://www.ukctg.nihr.ac.uk/ See where a study is open across the country http://public-odp.nihr.ac.uk/  Search for a study to fit criteria. Good for horizon scanning, eligibility criteria

Contacts Research Delivery Manager – maxine.taylor@nihr.ac.uk Cancer portfolio facilitator – sarah.west@nihr.ac.uk