Last updated on May 2018

Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy

Brief description of study

The purpose of this trial is to compare the efficacy and safety of Inotuzumab Ozogamicin in combination with R-CVP with that of R-G-CVP for the treatment of Diffuse Large B Cell Lymphoma (DLBCL) in a population of patients not suitable for anthracycline based chemotherapy.

There is no standard of care for the treatment of this group of patients. If demonstrated to be efficacious and safe to deliver this regimen will be further tested in a phase III trial to determine whether this should become the standard of care amongst patients with DLBCL not fit for anthracycline (R-CHOP).

Detailed Study Description

The incidence of DLBCL is increasing and with an expanding elderly population, the incidence will continue to rise. Given that about 40% of cases of DLBCL occur in patients aged over 70 and the number of co-mobilities increases with age, research to investigate the optimal treatment of DLBCL in this group of patients is needed. R-CHOP remains the standard of care for the majority of patients with DLBCL, anthracycline use is precluded in a proportion of these patients by a high risk of developing cardiotoxicity, especially congestive cardiac failure. Currently there is no standard of care for patients who are unfit for anthracycline treatment. It has been routine to omit the doxorubicin from R-CHOP, giving R-CVP instead. However the outcome for patients treated with R-CVP is poor and attempts have been made to replace the doxorubicin with alternative agents. The trial will compare an experimental arm consisting of Inotuzumab Ozogamicin added to the standard immunochemotherapy regimen of rituximab, cyclophosphamide, vincristine and prednisolone (R-CVP) with the control arm of gemcitabine added to the same combination (Gem-R-CVP).

Clinical Study Identifier: NCT01679119

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Beena Pushkaran

Stoke Mandeville Hospital (including Wycombe Hospital)
Aylesbury, United Kingdom
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Noel Ryman

North Hampshire Hospital
Basingstoke, United Kingdom
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Christopher Knechtli

Royal United Hospital
Bath, United Kingdom
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Lisa Lowry

Bristol Oncology Centre
Bristol, United Kingdom
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Mamtha Karanth

West Suffolk Hospital
Bury St Edmunds, United Kingdom
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Tariq Shafi

Darent Valley Hospital
Dartford, United Kingdom
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Maadh Abdul-Wahab Aldouri

Medway Maritime Hospital
Gillingham, United Kingdom
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Shalal Sadullah

James Paget University Hospital
Great Yarmouth, United Kingdom
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Nicki Panoskaltsis

Northwick Park Hospital
Harrow, United Kingdom
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INCA Trial Coordinator

Kent and Canterbury Hospital
Kent, United Kingdom
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Matthew Lyttelton

Kettering General Hospital
Kettering, United Kingdom
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Cathy Burton

St James's University Hospital
Leeds, United Kingdom
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Fiona Miall

Leicester Royal Infirmary
Leicester, United Kingdom
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Nagesh Kalakonda

Royal Liverpool University Hospital
Liverpool, United Kingdom
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Paul Fields

Guy's Hospital (including St Thomas's Hospital)
London, United Kingdom
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INCA Trial Coordinator

Royal Free Hospital
London, United Kingdom
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Kate Cwynarski

University College London Hospital
London, United Kingdom
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Peter Hoskin

Luton and Dunstable Hospital
Luton, United Kingdom
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Kim Linton

Christie Hospital
Manchester, United Kingdom
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Anne Lennard

Freeman Hospital
Newcastle, United Kingdom
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Nimish Shah

Norfolk and Norwich University Hospital
Norwich, United Kingdom
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Andrew McMillan

Nottingham City Hospital
Nottingham, United Kingdom
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INCA Trial Coordinator

Princess Royal University Hospital
Orpington, United Kingdom
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Graham Collins

Churchill Hospital
Oxford, United Kingdom
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Simon Rule

Derriford Hospital
Plymouth, United Kingdom
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Paul Greaves

Queen's Hospital
Romford, United Kingdom
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Andy Davies

Southampton General Hospital
Southampton, United Kingdom
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Steve Jones

Kings Mill Hospital
Sutton-in-Ashfield, United Kingdom
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Deborah Turner

Torbay Hospital
Torquay, United Kingdom
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Bryson Pottinger

Royal Cornwall Hospital
Truro, United Kingdom
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Katherine Lowndes

Royal Hampshire County Hospital
Winchester, United Kingdom
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Simon Watt

Wythenshawe Hospital (including Trafford General Hospital)
Wythenshawe, United Kingdom
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Renata Walewska

Royal Bournemouth Hospital
Bournemouth, United Kingdom
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Rusell Patmore

Castle Hill Hospital
Cottingham, United Kingdom
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Simon Watt

University Hospital, Coventry
Coventry, United Kingdom
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Paul Kerry

Royal Devon & Exeter Hospital
Exeter, United Kingdom
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Pam McKay

Beatson West of Scotland Cancer Centre (including Gartnavel Royal Hospital)
Glasgow, United Kingdom
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Jeffery Smith

Aintree University Hospital
Liverpool, United Kingdom
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Mari Kilner

North Tyneside Hosptial (including Wansbeck Hospital and Hexham General Hospital)
North Shields, United Kingdom
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Mark Crowther

Worcester Royal Hospital (including Kidderminster Hospital and Alexandra Hospital)
Worcester, United Kingdom
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Recruitment Status: Open

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