Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma
NCT ID: NCT00006250
Last Updated: 2013-09-20
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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UNKNOWN
PHASE3
500 participants
INTERVENTIONAL
2000-05-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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chlorambucil
dexamethasone
fludarabine phosphate
mitoxantrone hydrochloride
Eligibility Criteria
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Inclusion Criteria
* Histologically proven newly diagnosed stage III or IV follicular non-Hodgkin's lymphoma
* REAL classification grade I, II, or III
* Treatment necessity indicated by presence of the following:
* B symptoms
* Bone marrow failure
* Bulky or progressive disease
* Compression syndromes
* No CNS involvement
PATIENT CHARACTERISTICS:
Age:
* 18 to 70
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* No autoimmune hemolytic anemia or active hemolysis
* Direct Coombs' negative
Hepatic:
* Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN)\*
* Bilirubin no greater than 2.5 times ULN\* NOTE: \*Unless attributable to lymphoma
Renal:
* Creatinine no greater than 2.5 times ULN (unless attributable to lymphoma)
Cardiovascular:
* No severe cardiac failure
* Ejection fraction at least 45%
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for at least 6 months after study
* HIV negative
* No prior malignancy except carcinoma in situ of the cervix or squamous cell skin cancer
* No other serious medical disease that would limit lifespan or ability to tolerate chemotherapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* No concurrent systemic corticosteroids
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No prior therapy
18 Years
70 Years
ALL
No
Sponsors
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Lymphoma Trials Office
OTHER
Principal Investigators
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Andy Haynes, MD
Role: STUDY_CHAIR
Nottingham City Hospital
Locations
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Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, United Kingdom
Basildon University Hospital
Basildon, England, United Kingdom
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom
Bradford Hospitals NHS Trust
Bradford, England, United Kingdom
Kent and Canterbury Hospital
Canterbury, England, United Kingdom
St Helier Hospital
Carshalton, England, United Kingdom
Saint Richards Hospital
Chichester, England, United Kingdom
Walsgrave Hospital
Coventry, England, United Kingdom
Dartford & Gravesham NHS Trust, Joyce Green Hospital
Dartford Kent, England, United Kingdom
Derbyshire Royal Infirmary
Derby, England, United Kingdom
Doncaster Royal Infirmary
Doncaster, England, United Kingdom
Russells Hall Hospital
Dudley, England, United Kingdom
Epsom General Hospital
Epsom Surrey, England, United Kingdom
Northwick Park Hospital
Harrow, England, United Kingdom
Wycombe General Hospital
High Wycombe, England, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, United Kingdom
Hull Royal Infirmary
Hull, England, United Kingdom
Ipswich Hospital NHS Trust
Ipswich, England, United Kingdom
West Middlesex University Hospital
Isleworth, England, United Kingdom
Kettering General Hosptial
Kettering, Northants, England, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, 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
Leicester Royal Infirmary
Leicester, England, United Kingdom
Aintree University Hospital
Liverpool, England, United Kingdom
St. Thomas' Hospital
London, England, United Kingdom
St. Georges, University of London
London, England, United Kingdom
Great Ormond Street Hospital for Children NHS Trust
London, England, United Kingdom
University College of London Hospitals
London, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Pontefract General Infirmary
Pontefract West Yorkshire, England, United Kingdom
Oldchurch Hospital
Romford, England, United Kingdom
Rotherham District General Hospital - NHS Trust
Rotherham, England, United Kingdom
Pembury Hospital
Royal Tunbridge Wells, Kent, England, United Kingdom
Scunthorpe General Hospital
Scunthorpe, England, United Kingdom
Royal Hallamshire Hospital
Sheffield, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Staffordshire General Hospital
Stafford, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom
Taunton and Somerset Hospital
Taunton Somerset, England, United Kingdom
Torbay Hospital
Torquay Devon, England, United Kingdom
Hillingdon Hospital
Uxbridge, England, United Kingdom
Sandwell General Hospital
West Bromwich, England, United Kingdom
Good Hope Hospital Trust
West Midlands, England, United Kingdom
New Cross Hospital
Wolverhampton, England, United Kingdom
Worthing Hospital
Worthing, England, United Kingdom
Yeovil District Hospital
Yeovil - Somerset, England, United Kingdom
Cancer Care Centre at York Hospital
York, England, United Kingdom
Centre for Cancer Research and Cell Biology at Belfast City Hospital
Belfast, Northern Ireland, United Kingdom
Craigavon Area Hospital
Craigavon, Northern Ireland, United Kingdom
Ulster Hospital
Dundonald, Northern Ireland, United Kingdom
Pinderfields Hospital NHS Trust
Wakefield, Scotland, United Kingdom
Ysbyty Gwynedd
Bangor, Wales, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Glan Clywd District General Hospital
Rhyl, Denbighshire, Wales, United Kingdom
Singleton Hospital of the Swansea NHS Trust
Swansea, Wales, United Kingdom
Countries
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Other Identifiers
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BNLI-MCD/FMD
Identifier Type: -
Identifier Source: secondary_id
EU-20035
Identifier Type: -
Identifier Source: secondary_id
CDR0000068182
Identifier Type: -
Identifier Source: org_study_id