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Spots Global Cancer Trial Database for A Randomised Evaluation of Molecular Guided Therapy for Diffuse Large B-cell Lymphoma With Bortezomib

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Prof Peter Johnson

Affiliation: University Hospital Southampton NHS Foundation Trust

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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