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Brief Title: Randomised Trial in Waldenstrom's Macroglobulinaemia
Official Title: Subcutaneous Bortezomib, Cyclophosphamide and Rituximab (BCR) Versus Fludarabine, Cyclophosphamide and Rituximab (FCR) for Initial Therapy of Waldenstrőm's Macroglobulinaemia (WM): a Randomized Phase II Trial
Study ID: NCT01592981
Brief Summary: The purpose of this trial is to assess tolerability and efficacy of the Bortezomib, Cyclophosphamide and Rituximab combination as initial therapy for previously untreated patients with symptomatic Waldenstrom's macroglobulinaemia.
Detailed Description: Waldenstrom macroglobulinaemia (WM) is a low grade nonHodgkin lymphoma characterised by bone marrow infiltration and the presence of an abnormal protein in the blood (IgM paraprotein. Most patients require treatment at presentation but there is no agreed standard of first line therapy. Current treatment is unsatisfactory with responses often incomplete and slow to attain, while recurrence is inevitable. The aim of this study is to find out whether a new combination of Bortezomib (Velcade®), Cyclophosphamide and Rituximab (MabThera), is well tolerated and effective for patients with WM. R2W is a randomised, noncomparative, phase II trial of subcutaneous bortezomib, cyclophosphamide, rituximab (BCR, experimental arm) versus fludarabine, cyclophosphamide, rituximab (FCR, control arm) for initial therapy of WM. This is a two stage trial where six patients will be treated initially with BCR to assess tolerability. If BCR is considered tolerable, a further 50 patients will be randomised between BCR and FCR (2:1) in the second stage of the trial. Patients will receive 3 cycles of treatment and then be reassessed. Those with evidence of progression will stop trial treatment. All other patients will continue with a further 3 cycles (to a total of 6) unless there is a clear clinical contraindication to further treatment.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Basingstoke & North Hampshire Hospital, Basingstoke, , United Kingdom
Royal United Hospital, Bath, , United Kingdom
Birmingham Heartlands Hospital, Birmingham, , United Kingdom
City Hospital, Birmingham, , United Kingdom
Pilgrim Hospital, Boston, , United Kingdom
Colchester General Hospital, Colchester, , United Kingdom
Darent Valley Hospital, Dartford, , United Kingdom
Dewsbury and District Hospital, Dewsbury, , United Kingdom
Royal Devon and Exeter Hospital, Exeter, , United Kingdom
Grantham and District Hospital, Grantham, , United Kingdom
St James University Hospital, Leeds, , United Kingdom
Leicester Royal Infirmary, Leicester, , United Kingdom
Lincoln County Hospital, Lincoln, , United Kingdom
Royal Liverpool University Hospital, Liverpool, , United Kingdom
St Bartolomew's Hospital, London, , United Kingdom
University College Hospital, London, , United Kingdom
King's College Hospital, London, , United Kingdom
Northwick Park Hospital, London, , United Kingdom
Royal Free Hospital, London, , United Kingdom
Maidstone Hospital, Maidstone, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
Pontefract Hospital, Pontefract, , United Kingdom
Queen's Hospital, Romford, , United Kingdom
Salisbury District Hospital, Salisbury, , United Kingdom
Musgrove Park Hospital, Taunton, , United Kingdom
Torbay Hospital, Torquay, , United Kingdom
Tunbridge Wells Hospital, Tunbridge Wells, , United Kingdom
Pinderfields Hospital, Wakefield, , United Kingdom
Sandwell Hospital, West Bromwich, , United Kingdom
Royal Hampshire County Hospital, Winchester, , United Kingdom
Name: Rebecca Auer
Affiliation: St. Bartholomew's Hospital
Role: PRINCIPAL_INVESTIGATOR