Chlorambucil or Fludarabine as First-Line Therapy in Treating Patients With Previously Untreated Waldenström Macroglobulinemia, Splenic Lymphoma, or Lymphoplasmacytic Lymphoma
NCT ID: NCT00608374
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
400 participants
INTERVENTIONAL
2006-06-30
2013-01-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying chlorambucil to see how well it works compared with fludarabine as first-line therapy in treating patients with previously untreated Waldenström macroglobulinemia, splenic lymphoma, or lymphoplasmacytic lymphoma.
Detailed Description
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* Compare the efficacy of first-line therapy comprising chlorambucil vs fludarabine phosphate in patients with previously untreated Waldenström macroglobulinemia, splenic lymphoma with villous lymphocytes, or non-IgM lymphoplasmacytic lymphoma.
OUTLINE: This is a multicenter study. Patients are stratified according to disease (Waldenström macroglobulinemia vs splenic lymphoma with villous lymphocytes vs non-IgM lymphoplasmacytic lymphoma). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral chlorambucil on days 1-10. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive fludarabine phosphate orally or IV on days 1-5. Treatment repeats every 28 days for 3-6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo quality of life assessment at baseline.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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chlorambucil
fludarabine phosphate
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* Performance status 0-2
* Life expectancy \> 6 months
* Serum creatinine \< 200 mmol/L
* AST and ALT \< 2 times upper limit of normal
* Negative direct Coomb's test
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
* No severe or life-threatening cardiac, pulmonary, neurological, psychiatric, or metabolic disease
* No other concurrent malignancy
* No AIDS or AIDS-related complex
* No evidence of active hepatitis C infection
PRIOR CONCURRENT THERAPY:
* Prior plasmapheresis for control of clinically significant hyperviscosity allowed
* Prior splenectomy for SLVL allowed
18 Years
ALL
No
Sponsors
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Taunton and Somerset Hospital
OTHER
Principal Investigators
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Roger G. Owen, MD, MRCP
Role: STUDY_CHAIR
Leeds Cancer Centre at St. James's University Hospital
Locations
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Canberra Hospital
Garran, Australian Capital Territory, Australia
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Queen Elizabeth Hospital
Woodville, South Australia, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, United Kingdom
North Devon District Hospital
Barnstaple, England, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom
Royal United Hospital
Bath, England, United Kingdom
City Hospital - Birmingham
Birmingham, England, United Kingdom
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom
Blackpool Victoria Hospital
Blackpool, England, United Kingdom
Royal Bournemouth Hospital
Bournemouth, England, United Kingdom
Bradford Royal Infirmary
Bradford, England, United Kingdom
Queen's Hospital
Burton-on-Trent, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom
Saint Richards Hospital
Chichester, England, United Kingdom
Doncaster Royal Infirmary
Doncaster, England, United Kingdom
Russells Hall Hospital
Dudley, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Gloucestershire Royal Hospital
Gloucester, England, United Kingdom
Harrogate District Hospital
Harrogate, England, United Kingdom
Hereford Hospitals
Hereford, England, United Kingdom
Watford General Hospital
Herts, England, United Kingdom
Wycombe General Hospital
High Wycombe, England, United Kingdom
Hull Royal Infirmary
Hull, England, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, England, United Kingdom
Leeds General Infirmary
Leeds, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
University College Hospital - London
London, England, United Kingdom
Royal Manchester Children's Hospital
Manchester, England, United Kingdom
Trafford General Hospital
Manchester, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Pontefract General Infirmary
Pontefract West Yorkshire, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, United Kingdom
Rotherham General Hospital
Rotherham, England, United Kingdom
Wexham Park Hospital
Slough, Berkshire, England, United Kingdom
Staffordshire General Hospital
Stafford, England, United Kingdom
Taunton and Somerset Hospital
Taunton Somerset, England, United Kingdom
Torbay Hospital
Torquay, England, United Kingdom
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom
Kent and Sussex Hospital
Tunbridge Wells, Kent, England, United Kingdom
Sandwell General Hospital
West Bromwich, England, United Kingdom
New Cross Hospital
Wolverhampton, England, United Kingdom
Monklands General Hospital
Airdrie, Scotland, United Kingdom
Southern General Hospital
Glasgow, Scotland, United Kingdom
Pinderfields General Hospital
Wakefield, Scotland, United Kingdom
Ysbyty Gwynedd
Bangor, Wales, United Kingdom
Countries
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References
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Leblond V, Johnson S, Chevret S, Copplestone A, Rule S, Tournilhac O, Seymour JF, Patmore RD, Wright D, Morel P, Dilhuydy MS, Willoughby S, Dartigeas C, Malphettes M, Royer B, Ewings M, Pratt G, Lejeune J, Nguyen-Khac F, Choquet S, Owen RG. Results of a randomized trial of chlorambucil versus fludarabine for patients with untreated Waldenstrom macroglobulinemia, marginal zone lymphoma, or lymphoplasmacytic lymphoma. J Clin Oncol. 2013 Jan 20;31(3):301-7. doi: 10.1200/JCO.2012.44.7920. Epub 2012 Dec 10.
Nguyen-Khac F, Lambert J, Chapiro E, Grelier A, Mould S, Barin C, Daudignon A, Gachard N, Struski S, Henry C, Penther D, Mossafa H, Andrieux J, Eclache V, Bilhou-Nabera C, Luquet I, Terre C, Baranger L, Mugneret F, Chiesa J, Mozziconacci MJ, Callet-Bauchu E, Veronese L, Blons H, Owen R, Lejeune J, Chevret S, Merle-Beral H, Leblondon V; Groupe Francais d'Etude de la Leucemie Lymphoide Chronique et Maladie de Waldenstrom (GFCLL/MW); Groupe Ouest-Est d'etude des Leucemie Aigues et Autres Maladies du Sang (GOELAMS); Groupe d'Etude des Lymphomes de l'Adulte (GELA). Chromosomal aberrations and their prognostic value in a series of 174 untreated patients with Waldenstrom's macroglobulinemia. Haematologica. 2013 Apr;98(4):649-54. doi: 10.3324/haematol.2012.070458. Epub 2012 Oct 12.
Other Identifiers
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TSH-WM1
Identifier Type: -
Identifier Source: secondary_id
ISRCTN56052618
Identifier Type: -
Identifier Source: secondary_id
CDR0000581143
Identifier Type: -
Identifier Source: org_study_id