Chlorambucil or Fludarabine as First-Line Therapy in Treating Patients With Previously Untreated Waldenström Macroglobulinemia, Splenic Lymphoma, or Lymphoplasmacytic Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00608374
- Lead Sponsor
- Taunton and Somerset Hospital
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as chlorambucil and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether chlorambucil is more effective than fludarabine in treating Waldenström macroglobulinemia, splenic lymphoma, or lymphoplasmacytic lymphoma.
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
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response to therapy (complete and partial response rates) Duration of response
- Secondary Outcome Measures
Name Time Method Improvement in hematological parameters Toxicity Quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life-30 questionnaire Survival
Trial Locations
- Locations (48)
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
Bradford Royal Infirmary
🇬🇧Bradford, England, United Kingdom
Birmingham Heartlands Hospital
🇬🇧Birmingham, England, United Kingdom
Gloucestershire Royal Hospital
🇬🇧Gloucester, England, United Kingdom
Newcastle Mater Misericordiae Hospital
🇦🇺Waratah, New South Wales, Australia
Royal United Hospital
🇬🇧Bath, England, United Kingdom
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom
Taunton and Somerset Hospital
🇬🇧Taunton Somerset, England, United Kingdom
Staffordshire General Hospital
🇬🇧Stafford, England, United Kingdom
Torbay Hospital
🇬🇧Torquay, England, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, England, United Kingdom
Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
Russells Hall Hospital
🇬🇧Dudley, England, United Kingdom
Royal Manchester Children's Hospital
🇬🇧Manchester, England, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
🇬🇧Basingstoke, England, United Kingdom
Sandwell General Hospital
🇬🇧West Bromwich, England, United Kingdom
Doncaster Royal Infirmary
🇬🇧Doncaster, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
City Hospital - Birmingham
🇬🇧Birmingham, England, United Kingdom
Harrogate District Hospital
🇬🇧Harrogate, England, United Kingdom
Rotherham General Hospital
🇬🇧Rotherham, England, United Kingdom
Queen's Hospital
🇬🇧Burton-upon-Trent, England, United Kingdom
Kent and Sussex Hospital
🇬🇧Tunbridge Wells, Kent, England, United Kingdom
Queen Elizabeth Hospital
🇬🇧King's Lynn, England, United Kingdom
Watford General Hospital
🇬🇧Herts, England, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, England, United Kingdom
Hull Royal Infirmary
🇬🇧Hull, England, United Kingdom
Pinderfields General Hospital
🇬🇧Wakefield, Scotland, United Kingdom
Saint Richards Hospital
🇬🇧Chichester, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
🇬🇧Reading, England, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, Cornwall, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
University College Hospital - London
🇬🇧London, England, United Kingdom
Trafford General Hospital
🇬🇧Manchester, England, United Kingdom
Hereford Hospitals
🇬🇧Hereford, England, United Kingdom
Wycombe General Hospital
🇬🇧High Wycombe, England, United Kingdom
Pontefract General Infirmary
🇬🇧Pontefract West Yorkshire, England, United Kingdom
Wexham Park Hospital
🇬🇧Slough, Berkshire, England, United Kingdom
Southern General Hospital
🇬🇧Glasgow, Scotland, United Kingdom
Derriford Hospital
🇬🇧Plymouth, England, United Kingdom
Stoke Mandeville Hospital
🇬🇧Aylesbury-Buckinghamshire, England, United Kingdom
North Devon District Hospital
🇬🇧Barnstaple, England, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, England, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Monklands General Hospital
🇬🇧Airdrie, Scotland, United Kingdom
Ysbyty Gwynedd
🇬🇧Bangor, Wales, United Kingdom