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Brief Title: A Trial Looking at Ofatumumab for People With Chronic Lymphocytic Leukaemia Who Cannot Have More Intensive Treatment
Official Title: A Randomised Investigation of Alternative Ofatumumab-containing Regimens in Less Fit Patients With CLL
Study ID: NCT01678430
Brief Summary: The purpose of this study is to compare ofatumumab \& chlorambucil (O-Chl) versus ofatumumab \& bendamustine (O-B) in patients with Chronic Lymphocytic Leukaemia who are considered not fit enough for rituximab, fludarabine \& cyclophosphamide (R-FC).
Detailed Description: Chlorambucil (Chl) has been the mainstay of CLL treatment for half a century. However, frontline treatment has improved considerably over the last decade, first by the advent of fludarabine plus cyclophosphamide (FC), and more recently by the addition of the anti-CD20 antibody, rituximab, to FC. Although FC-based regimens are considerably more effective than Chl, they are also associated with greater toxicity which makes them inappropriate for less fit patients. This is an important consideration, given that CLL predominantly affects older people who tend to have more co-morbidity. Although a single-arm phase II study (Roche MO20927; NCRI CLL208) has shown that R-Chl is safe and effective, there are no phase III data proving the benefit of adding an anti-CD20 antibody to Chl. This question is currently being addressed by a phase III RCT of Chl with or without ofatumumab (GSK OMB110911 / COMPLEMENT-1 / NCRI CLL7). Ofatumumab is a fully human anti-CD20 antibody that binds to an epitope distinct from that of rituximab and produces more complement-dependent cytotoxicity. The RIAltO trial is a direct follow-on to the NCRI CLL7 phase III RCT trial in less fit patients and therefore the Ofatumumab dose has been selected to mirror the regimen used in that trial.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Countess of Chester Hospital, Chester, Cheshire, United Kingdom
Derriford Hospital, Plymouth, Devon, United Kingdom
Torbay Hospital, Torquay, Devon, United Kingdom
Royal Bournemouth Hospital, Bournemouth, Dorset, United Kingdom
Dorset County Hospital, Dorchester, Dorset, United Kingdom
Colchester General Hospital, Colchester, Essex, United Kingdom
Basingstoke and North Hampshire Hospital, Basingstoke, Hampshire, United Kingdom
Southampton General Hospital, Southampton, Hampshire, United Kingdom
Barnet and Chase Farm Hospitals, Enfield, Hertfordshire, United Kingdom
Kent and Canterbury Hospital, Canterbury, Kent, United Kingdom
Maidstone Hospital, Maidstone, Kent, United Kingdom
Princess Royal Hospital, Orpington, Kent, United Kingdom
Queen Elizabeth Hospital, Woolwich, London, United Kingdom
West Middlesex University Hospital, Isleworth, Middlesex, United Kingdom
Ealing Hospital, Southall, Middlesex, United Kingdom
Hillingdon Hospital, Uxbridge, Middlesex, United Kingdom
Belfast City Hospital, Belfast, Northern Ireland, United Kingdom
Royal United Hospital, Bath, Somerset, United Kingdom
Weston General Hospital, Weston-super-Mare, Somerset, United Kingdom
Queens Hospital, Burton-upon-Trent, Staffordshire, United Kingdom
Queen Elizabeth Hospital, Gateshead, Tyne and Wear, United Kingdom
Queen Elizabeth Hospital, Birmingham, West Midlands, United Kingdom
Bradford Royal Infirmary, Bradford, West Yorkshire, United Kingdom
Airdale General Hospital, Keighley, West Yorkshire, United Kingdom
St James University Hospital, Leeds, West Yorkshire, United Kingdom
Salisbury District Hospital, Salisbury, Wiltshire, United Kingdom
Arrowe Park Hospital, Upton, Wirral, United Kingdom
Royal Liverpool Hospital, Liverpool, , United Kingdom