Study Results
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Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2013-01-31
2020-08-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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bortezomib, cyclophosphamide, rituximab
Bortezomib:1.6 mg/m2 s.c; days 1, 8, 15 of each cycle. Cyclophosphamide:250 mg/m2 oral; days 1, 8, 15 of each cycle. Rituximab: 375 mg/m2 i.v. infusion; days 1, 8, 15 and 22 of cycles 2 and 5 only.
Cycle repeated every 28 days. After 3 cycles of treatment, patients are reassessed and those with evidence of progression stop trial treatment. All other patients continue with further 3 cycles (to a total of 6) unless a clear clinical contradiction to further treatment exist.
Bortezomib
1.6 mg/m2 subcutaneous bortezomib on days1, 8 and 15 of 28 days cycle
Cyclophosphamide
Cyclophosphamide:250 mg/sq m, oral, days 1, 8 and 15 of each cycle in the experimental arm.
Cyclophosphamide:250 mg/sq m, oral, days 1, 2 and 3 of each cycle in the control arm.
Rituximab
Rituximab: 375 mg/m2 i.v. infusion; days 1, 8, 15 and 22 of cycles 2 and 5 only
fludarabine, cyclophosphamide, rituximab
Fludarabine:40 mg/sq m, oral, days 1,2 and 3 of each cycle. Cyclophosphamide:250 mg/sq m; oral, days 1, 2 and 3 of each cycle. Rituximab: 375 mg/sq m i.v. infusion days 1, 8, 15 and 22 of cycles 2 and 5 only.
Cycle repeated every 28 days.After 3 cycles of treatment, patients are reassessed and those with evidence of progression stop trial treatment. All other patients continue with further 3 cycles (to a total of 6) unless a clear clinical contradiction to further treatment exist.
Cyclophosphamide
Cyclophosphamide:250 mg/sq m, oral, days 1, 8 and 15 of each cycle in the experimental arm.
Cyclophosphamide:250 mg/sq m, oral, days 1, 2 and 3 of each cycle in the control arm.
Rituximab
Rituximab: 375 mg/m2 i.v. infusion; days 1, 8, 15 and 22 of cycles 2 and 5 only
Fludarabine
Fludarabine: 40 mg/sq m, oral, days 1, 2 and 3
Interventions
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Bortezomib
1.6 mg/m2 subcutaneous bortezomib on days1, 8 and 15 of 28 days cycle
Cyclophosphamide
Cyclophosphamide:250 mg/sq m, oral, days 1, 8 and 15 of each cycle in the experimental arm.
Cyclophosphamide:250 mg/sq m, oral, days 1, 2 and 3 of each cycle in the control arm.
Rituximab
Rituximab: 375 mg/m2 i.v. infusion; days 1, 8, 15 and 22 of cycles 2 and 5 only
Fludarabine
Fludarabine: 40 mg/sq m, oral, days 1, 2 and 3
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of WM (according to consensus panel / WHO criteria) with measurable IgM paraprotein
* Previously untreated disease at any stage requiring therapy at the discretion of the treating physician. Suggested criteria for initiating treatment include:
* haematological suppression to Hb \<10 g/dl, or neutrophils \<1.5x109/l or platelets \<150x109/l
* clinical evidence of hyperviscosity
* bulky lymphadenopathy and/or bulky splenomegaly
* presence of B symptoms
* No previous chemotherapy (prior plasma exchange and steroids are permissible)
* Performance status grade 0 - 2
* Life expectancy of greater than 6 months
* Informed consent
* Agreed compliance with recommended contraceptive precautions where appropriate
Exclusion Criteria
* Severe pre-existing neuropathy (\> grade 2)
* Autoimmune cytopenias
* Evidence of active Hepatitis B or C infection (patients with evidence of past HepB infection may be eligible - see appendix 6)
* Serological positivity for HIV
* Pregnant or lactating women
* Life expectancy severely limited by other illness
* Renal failure (creatinine clearance \<30 ml/min)
* Severe impairment of liver function: alkaline phosphatase/bilirubin \>2.5 times upper limit of normal (ULN), ALT/AST \>2.5 times ULN not related to lymphoma (patients with Gilbert syndrome are eligible)
* History of allergic reaction to compounds containing boron or mannitol
* Known hypersensitivity to murine compounds.
* Diagnosed or treated for a malignancy other than WM within 5 years before day 1 of Cycle 1 with the exception of complete resection of basal cell carcinoma, squamous cell carcinoma of the skin or any other in situ malignancy
* Active systemic infection requiring treatment
* Concurrent treatment with another investigational agent
* Severe or life-threatening cardiac, pulmonary, neurological, psychiatric or metabolic disease
18 Years
ALL
No
Sponsors
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University College, London
OTHER
Responsible Party
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Principal Investigators
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Rebecca Auer
Role: PRINCIPAL_INVESTIGATOR
St. Bartholomew's Hospital
Locations
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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
Tunbridge Wells Hospital
Royal Tunbridge Wells, , United Kingdom
Salisbury District Hospital
Salisbury, , United Kingdom
Musgrove Park Hospital
Taunton, , United Kingdom
Torbay Hospital
Torquay, , United Kingdom
Pinderfields Hospital
Wakefield, , United Kingdom
Sandwell Hospital
West Bromwich, , United Kingdom
Royal Hampshire County Hospital
Winchester, , United Kingdom
Countries
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Other Identifiers
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UCL/11/0353
Identifier Type: -
Identifier Source: org_study_id
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