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Spots Global Cancer Trial Database for Randomised Trial in Waldenstrom's Macroglobulinaemia

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Rebecca Auer

Affiliation: St. Bartholomew's Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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