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Brief Title: A Randomised Evaluation of Molecular Guided Therapy for Diffuse Large B-cell Lymphoma With Bortezomib
Official Title: A Randomised Evaluation of Molecular Guided Therapy for Diffuse Large B-cell Lymphoma With Bortezomib
Study ID: NCT01324596
Brief Summary: The aims of this study are: * To evaluate the benefits of the addition of bortezomib to standard rituximab with cyclophosphamide, doxorubicin, vincristine, prednisolone (R-CHOP) therapy in Diffuse Large B-cell Lymphoma (DLBCL). * To determine whether molecular phenotype effects the benefits derived from the addition of bortezomib.
Detailed Description: REMoDLB is a trial which aims to determine whether the addition of bortezomib (a drug that blocks the action of cellular complexes that break down proteins) to standard combination chemotherapy (called R-CHOP) improves how long patients with diffuse large B cell lymphoma survive without a recurrence of the disease. Results from recent research have suggested that patients can be divided into two biologically distinct subgroups labeled GCB (germinal centre derived B-cells like) and ABC (activated peripheral B-cells like). GCB patients tend to do well with standard combination chemotherapy, but ABC patients have the majority of treatment failures. It is thought that ABC patients will benefit most from the addition of bortezomib. The trial will be discussed with the patient. They will be asked to consent to molecular profiling of their tumour block whilst they have some time to consider whether they wish to enter the main trial. This will allow more time for this sample to be analysed and their particular biological subgroup to be determined. All patients consenting to enter the main study will be given an initial cycle of RCHOP chemotherapy. Within each subgroup (ABC or GCB) patients will be randomly assigned to receive either RCHOP or RCHOP and bortezomib to ensure that the same number of each biological subgroup will receive the two treatments. All patients will then have 5 cycles of their assigned treatment regimen (either RCHOP or RCHOP and bortezomib). All patients will be followed up for a period of five years once they have completed their chemotherapy. The GCB group receiving RCHOP and bortezomib will be regularly checked to see if the new treatment is improving survival without recurrence of the disease. If the addition of bortezomib is not found to be beneficial for this group of patients this part of the trial will be stopped and all GCB patients will receive the standard treatment only (RCHOP). It is anticipated that between 560 and 892 patients will be randomly allocated to the two treatments, the exact number depends on whether the GCB group receiving RCHOP and bortezomib is stopped or not.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Kantonsspital Aarau, Aarau, , Switzerland
Kantonsspital Liestal, Basel, , Switzerland
Universitatsspital Basel, Basel, , Switzerland
Ospedale Regionale Bellinzona e Valli (IOSI), Bellinzona, , Switzerland
Inselspital Bern, Bern, , Switzerland
STSAG Thun, Bern, , Switzerland
Spitalzenturm Oberwallis, Brig, , Switzerland
Kantonsspital Graubunden, Chur, , Switzerland
Luzerner Kantonsspital, Lucerne, , Switzerland
Kantonsspital Olten, Olten, , Switzerland
Kantonsspital St. Gallen, St. Gallen, , Switzerland
Stadtspital Triemli, Zurich, , Switzerland
UniversitatsSpital Zurich, Zurich, , Switzerland
University Hospital Aintree, Aintree, , United Kingdom
Monklands, Hairmyres and Whishaw Hospitals, Airdrie, , United Kingdom
Antrim Area Hospital, Antrim, , United Kingdom
Stoke Mandeville Hospital and Wycombe Hospital, Aylesbury, , United Kingdom
Ysbyty Gwynedd Hospital, Bangor, , United Kingdom
Basildon Hospital, Basildon, , United Kingdom
North Hampshire & Basingstoke Hospital, Basingstoke, , United Kingdom
Royal United Hospital, Bath, , United Kingdom
Belfast City Hospital, Belfast, , United Kingdom
Arrowe Park, Birkenhead, , United Kingdom
Good Hope Hosptial, Birmingham, , United Kingdom
Queen Elizabeth Hospital, Birmingham, , United Kingdom
Sandwell General Hospital Birmingham, Birmingham, , United Kingdom
Victoria Hospital, Blackpool, , United Kingdom
Royal Bournemouth, Bournemouth, , United Kingdom
Bradford Royal Infirmary, Bradford, , United Kingdom
Queen's Hospital Burton, Burton upon Trent, , United Kingdom
West Suffolk Hospital, Bury St. Edmunds, , United Kingdom
Velindre Hospital, Cardiff, , United Kingdom
Broomfield Hospital, Chelmsford, , United Kingdom
Cheltenham General Hospital and Gloucestershire Royal Infirmary, Cheltenham, , United Kingdom
Chesterfield Royal, Chesterfield, , United Kingdom
St Richard's Hospital, Chichester, , United Kingdom
Colchester General Hospital, Colchester, , United Kingdom
University Hospital Coventry, Coventry, , United Kingdom
Darent Valley Hospital, Dartford, , United Kingdom
Royal Derby Hospitals, Derby, , United Kingdom
Doncaster Royal Infirmary, Doncaster, , United Kingdom
Ulster Hospital, Dundonald, , United Kingdom
Royal Devon and Exeter Hospital, Exeter, , United Kingdom
Queen Elizabeth Hospital, Gateshead, Gateshead, , United Kingdom
Medway Maritime Hospital, Gillingham, , United Kingdom
Beatson West of Scotland Cancer centre, Glasgow, , United Kingdom
Diana Princess of Wales, Grimsby, Grimsby, , United Kingdom
Harrogate District Hospital, Harrogate, , United Kingdom
Hemel Hempstead General and Watford General, Hemel Hempstead and Watford, , United Kingdom
Huddersfield Royal Infirmary, Huddersfield, , United Kingdom
Castle Hill Hospital, Hull, , United Kingdom
Raigmore Hospital, Inverness, , United Kingdom
Kent and Canterbury Hospital, Kent, , United Kingdom
Queen Elizabeth Hospital, King's Lynn, , United Kingdom
St James University Hospital, Leeds, , United Kingdom
Lincoln County Hospital, Pilgrim Hospital, Grantham and District Hospital, Lincoln, , United Kingdom
Royal Liverpool, Liverpool, , United Kingdom
Barnet General Hospital, London, , United Kingdom
Ealing Hospital, London, , United Kingdom
Guy's Hospital, London, , United Kingdom
Hammersmith Hospital, London, , United Kingdom
Hillingdon Hospital, London, , United Kingdom
King's College Hospital, London, , United Kingdom
Northwick Park Hospital, London, , United Kingdom
Princess Royal University Hospital, London, , United Kingdom
QE Woolwich, London, , United Kingdom
Royal Free Hospital, London, , United Kingdom
St Bartholomews Hospital, London, , United Kingdom
St George's Hospital, London, , United Kingdom
St Helier Hospital, London, , United Kingdom
The Royal Marsden, London, , United Kingdom
University College Hospital London, London, , United Kingdom
Luton and Dunstable Hospital, Luton, , United Kingdom
Maidstone Hospital and The Tunbridge Wells Hospital, Maidstone, , United Kingdom
Christie Hospital, Manchester, , United Kingdom
Manchester Royal Infirmary, Manchester, , United Kingdom
Wythenshawe Hospital, Manchester, , United Kingdom
The James Cook University Hospital, Middlesbrough, , United Kingdom
Milton Keynes General Hospital, Milton Keynes, , United Kingdom
Freeman Hospital, Newcastle, Newcastle, , United Kingdom
Northampton General Hospital, Northampton, , United Kingdom
Mount Vernon Hospital, Northwood, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
George Eliot Hospital, Nuneaton, , United Kingdom
Royal Oldham, Oldham, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
Poole General Hospital, Poole, , United Kingdom
Craigavon Area Hospital, Portadown, , United Kingdom
Queen Alexandra Hospital, Portsmouth, , United Kingdom
Royal Berkshire Hospital, Reading, , United Kingdom
Glan Clwyd District General Hospital, Rhyl, , United Kingdom
Queen's Hospital, Romford, , United Kingdom
Salisbury District Hospital, Salisbury, , United Kingdom
Scunthorpe General Hospital, Scunthorpe, , United Kingdom
Royal Hallamshire Hospital, Sheffield, , United Kingdom
Wexham Park, Slough, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Southend Hospital, Southend, , United Kingdom
County Hospital, Stafford, , United Kingdom
Royal Stoke Hospital, Stoke, , United Kingdom
Sunderland Royal Hospital, Sunderland, , United Kingdom
Great Western Hospital, Swindon, , United Kingdom
Torbay District General Hospital, Torbay, , United Kingdom
Royal Cornwall Hospital, Truro, , United Kingdom
Pinderfields Hospital, Dewsbury Hospital and Ponerfract Hospital, Wakefield, , United Kingdom
Warwick Hospital, Warwick, , United Kingdom
Worcestershire Royal Hospital, Worcester, , United Kingdom
Worthing Hospital, Worthing, , United Kingdom
Name: Prof Peter Johnson
Affiliation: University Hospital Southampton NHS Foundation Trust
Role: PRINCIPAL_INVESTIGATOR