Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00006250
- Lead Sponsor
- Lymphoma Trials Office
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
* Compare the overall survival rate, progression free survival rate, clinical and molecular remission rates, and time to treatment failure in patients with newly diagnosed stage III or IV follicular non-Hodgkin's lymphoma treated with chlorambucil, mitoxantrone, and dexamethasone versus fludarabine, mitoxantrone, and dexamethasone.
* Compare the efficacy and tolerability of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to International Prognostic Index score \[low risk (score 1) vs intermediate low risk (score 2) vs intermediate high risk (score 3) vs high risk (score 4 or 5)\]. Patients are randomized to one of two treatment arms.
* Arm I: Patients receive mitoxantrone IV on day 1, oral chlorambucil on days 1-10, and oral dexamethasone on days 1-5.
* Arm II: Patients receive mitoxantrone and dexamethasone as in arm I and fludarabine IV on days 1-3.
Treatment continues every 4 weeks for 4-8 courses.
Patients are followed at 3, 6, and 12 months, every 6 months for 1 year, and then annually thereafter until clinical relapse.
PROJECTED ACCRUAL: A total of 500 patients (250 per arm) will be accrued for this study within 4 years.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to treatment failure Progression-free survival rate Overall survival rate
- Secondary Outcome Measures
Name Time Method Clinical remission rate Molecular remission rate
Trial Locations
- Locations (59)
St. Thomas' Hospital
🇬🇧London, England, United Kingdom
Birmingham Heartlands Hospital
🇬🇧Birmingham, England, United Kingdom
Craigavon Area Hospital
🇬🇧Craigavon, Northern Ireland, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Pembury Hospital
🇬🇧Royal Tunbridge Wells, Kent, England, United Kingdom
Scunthorpe General Hospital
🇬🇧Scunthorpe, England, United Kingdom
Derbyshire Royal Infirmary
🇬🇧Derby, England, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil - Somerset, England, United Kingdom
Centre for Cancer Research and Cell Biology at Belfast City Hospital
🇬🇧Belfast, Northern Ireland, United Kingdom
Glan Clywd District General Hospital
🇬🇧Rhyl, Denbighshire, Wales, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
University College of London Hospitals
🇬🇧London, England, United Kingdom
Taunton and Somerset Hospital
🇬🇧Taunton Somerset, England, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, Wales, United Kingdom
Epsom General Hospital
🇬🇧Epsom Surrey, England, United Kingdom
Wycombe General Hospital
🇬🇧High Wycombe, England, United Kingdom
St Helier Hospital
🇬🇧Carshalton, England, United Kingdom
Kettering General Hosptial
🇬🇧Kettering, Northants, England, United Kingdom
Queen Elizabeth Hospital
🇬🇧King's Lynn, England, United Kingdom
Basildon University Hospital
🇬🇧Basildon, England, United Kingdom
Dartford & Gravesham NHS Trust, Joyce Green Hospital
🇬🇧Dartford Kent, England, United Kingdom
Ipswich Hospital NHS Trust
🇬🇧Ipswich, England, United Kingdom
Hillingdon Hospital
🇬🇧Uxbridge, England, United Kingdom
Sandwell General Hospital
🇬🇧West Bromwich, England, United Kingdom
St. Georges, University of London
🇬🇧London, England, United Kingdom
Saint Richards Hospital
🇬🇧Chichester, England, United Kingdom
Russells Hall Hospital
🇬🇧Dudley, England, United Kingdom
West Middlesex University Hospital
🇬🇧Isleworth, England, United Kingdom
Royal Hallamshire Hospital
🇬🇧Sheffield, England, United Kingdom
Stoke Mandeville Hospital
🇬🇧Aylesbury-Buckinghamshire, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Derriford Hospital
🇬🇧Plymouth, England, United Kingdom
Ulster Hospital
🇬🇧Dundonald, Northern Ireland, United Kingdom
Hull Royal Infirmary
🇬🇧Hull, England, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, England, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
Doncaster Royal Infirmary
🇬🇧Doncaster, England, United Kingdom
Good Hope Hospital Trust
🇬🇧West Midlands, England, United Kingdom
Rotherham District General Hospital - NHS Trust
🇬🇧Rotherham, England, United Kingdom
Pinderfields Hospital NHS Trust
🇬🇧Wakefield, Scotland, United Kingdom
Northwick Park Hospital
🇬🇧Harrow, England, United Kingdom
Huddersfield Royal Infirmary
🇬🇧Huddersfield, West Yorks, England, United Kingdom
Aintree University Hospital
🇬🇧Liverpool, England, United Kingdom
Staffordshire General Hospital
🇬🇧Stafford, England, United Kingdom
Great Ormond Street Hospital for Children NHS Trust
🇬🇧London, England, United Kingdom
Bradford Hospitals NHS Trust
🇬🇧Bradford, England, United Kingdom
Clinical Trials and Research Unit of the University of Leeds
🇬🇧Leeds, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Pontefract General Infirmary
🇬🇧Pontefract West Yorkshire, England, United Kingdom
Oldchurch Hospital
🇬🇧Romford, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
🇬🇧Sutton, England, United Kingdom
Torbay Hospital
🇬🇧Torquay Devon, England, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, England, United Kingdom
Worthing Hospital
🇬🇧Worthing, England, United Kingdom
Cancer Care Centre at York Hospital
🇬🇧York, England, United Kingdom
Ysbyty Gwynedd
🇬🇧Bangor, Wales, United Kingdom
Singleton Hospital of the Swansea NHS Trust
🇬🇧Swansea, Wales, United Kingdom