Chemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00004218
- Lead Sponsor
- Leukemia Research Fund
- 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 regimen of chemotherapy is more effective for chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying chlorambucil to see how well it works compared to fludarabine and cyclophosphamide or fludarabine alone in treating patients with newly diagnosed chronic lymphocytic leukemia.
- Detailed Description
OBJECTIVES:
* Compare the survival rate of patients with newly diagnosed chronic lymphocytic leukemia treated with chlorambucil alone vs fludarabine with or without cyclophosphamide.
* Compare the response rate and duration of remission in patients treated with these regimens.
* Compare the toxic effects of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
* Determine the impact of the drug response information provided by the DiSC assay on response rate and survival in relapsed or nonresponding patients.
* Assess the prognostic value of five genetic markers: trisomy 12 and deletions at 11q23, 13q14, p53, and 6q21 in patients treated with these regimens.
OUTLINE: This is a randomized study. Patients enter one of three treatment arms in the first randomization. Depending on response, some patients may also participate in a second randomization to one of two treatment arms.
* First randomization:
* Arm I: Patients receive oral chlorambucil daily for 7 days. Treatment repeats every 4 weeks until maximum response or up to 1 year.
* Arm II: Patients receive fludarabine IV or orally daily for 5 days. Treatment repeats every 4 weeks for 3-8 courses.
* Arm III: Patients receive cyclophosphamide IV and fludarabine IV for 3 days or orally daily for 5 days. Treatment repeats every 4 weeks for 3-8 courses.
Patients who relapse after being in remission for at least 1 year may repeat the initial therapy or may participate in a second randomization. Patients who experience progressive disease or relapse within 1 year after treatment proceed to a second randomization.
* Second randomization:
* Arm I: Treatment is guided by the results of the DiSC assay. Treatment may be one of the first-line treatments with fludarabine or standard CHOP chemotherapy repeated every 4 weeks (cyclophosphamide IV, doxorubicin IV, vincristine IV, and oral prednisolone on days 1-5) or any other therapy guided by the results of the DiSC assay.
* Arm II: Treatment is physician's choice, which may include any of the options in arm I.
Quality of life is assessed prior to initial therapy; at 3, 6, and 12 months; and then annually thereafter.
Patients are followed annually for survival.
PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study within 6-7 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (85)
Ospedali Riuniti di Bergamo
🇮🇹Bergamo, Italy
St. James' Hospital
🇮🇪Dublin, Ireland
North Hampshire Hospital
🇬🇧Basingstoke, England, United Kingdom
Selly Oak Hospital at University Hospital NHS Trust
🇬🇧Birmingham, England, United Kingdom
Hospital Alvarez
🇦🇷Buenos Aires, Argentina
Russian Academy of Medical Sciences Cancer Research Center
🇷🇺Moscow, Russian Federation
Stoke Mandeville Hospital
🇬🇧Aylesbury-Buckinghamshire, England, United Kingdom
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
Canterbury Health Laboratories
🇳🇿Christchurch, New Zealand
University of Patras Medical School
🇬🇷Rio Patras, Greece
Galway University Hospital
🇮🇪Galway, Ireland
University Hospital Rebro
ðŸ‡ðŸ‡·Zagreb, Croatia
University of Ioannina
🇬🇷Ioannina, Greece
Horton Hospital
🇬🇧Banbury, England, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, England, United Kingdom
Countess of Chester Hospital
🇬🇧Chester, England, United Kingdom
Russells Hall Hospital
🇬🇧Dudley, England, United Kingdom
Dartford & Gravesham NHS Trust, Joyce Green Hospital
🇬🇧Dartford Kent, England, United Kingdom
Epsom General Hospital
🇬🇧Epsom Surrey, England, United Kingdom
Northampton General Hospital NHS Trust
🇬🇧Northampton, England, United Kingdom
Whipps Cross Hospital
🇬🇧London, England, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Doncaster Royal Infirmary
🇬🇧Doncaster, England, United Kingdom
West Middlesex Hospital
🇬🇧Middlesex, England, United Kingdom
Queen Elizabeth Hospital
🇬🇧Gateshead, England, United Kingdom
Hemel Hempstead General
🇬🇧Hemel Hempstead, England, United Kingdom
Hull Royal Infirmary
🇬🇧Hull, England, United Kingdom
Farnborough Hospital
🇬🇧Orpington Kent, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Bassetlaw Hospital & Community Services NHS Trust
🇬🇧Nottinghamshire, England, United Kingdom
St. George's Hospital
🇬🇧London, England, United Kingdom
Royal Marsden NHS Foundation Trust - London
🇬🇧London, England, United Kingdom
Royal South Hants Hospital
🇬🇧Southampton, England, United Kingdom
Royal Alexandra Hospital
🇬🇧Paisley, Scotland, United Kingdom
Victoria Hospital
🇬🇧Kirkcaldy, Scotland, United Kingdom
Worthing Hospital
🇬🇧Worthing, England, United Kingdom
Staffordshire General Hospital
🇬🇧Stafford, England, United Kingdom
Good Hope Hospital Trust
🇬🇧West Midlands, England, United Kingdom
City Hospital - Birmingham
🇬🇧West Bromwich, England, United Kingdom
Cancer Care Centre at York Hospital
🇬🇧York, England, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Craigavon Area Hospital
🇬🇧Portadown, Craigavon, Northern Ireland, United Kingdom
Southern General Hospital
🇬🇧Glasgow, Scotland, United Kingdom
Raigmore Hospital
🇬🇧Inverness, Scotland, United Kingdom
Singleton Hospital
🇬🇧Swansea, Wales, United Kingdom
Dumfries Royal Infirmary
🇬🇧Dumfries, Scotland, United Kingdom
Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Birmingham Heartlands Hospital
🇬🇧Birmingham, England, United Kingdom
Aintree University Hospital
🇬🇧Liverpool, England, United Kingdom
Guy's and St. Thomas' Hospitals NHS Foundation Trust
🇬🇧London, England, United Kingdom
Northern Cancer Network
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
🇬🇧Reading, England, United Kingdom
Rotherham District General Hospital - NHS Trust
🇬🇧Rotherham, England, United Kingdom
St. Peter's Hospital NHS Trust
🇬🇧Surrey, England, United Kingdom
North Staffs Royal Infirmary
🇬🇧Stoke-On-Trent, England, United Kingdom
Monklands General Hospital
🇬🇧Airdrie, Scotland, United Kingdom
Ulster Hospital
🇬🇧Dundonald, Northern Ireland, United Kingdom
Nevill Hall Hospital
🇬🇧Gwent, Wales, United Kingdom
Bishop Auckland Hospital
🇬🇧Durham, England, United Kingdom
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Pontefract General Infirmary
🇬🇧Pontefract West Yorkshire, England, United Kingdom
Chesterfield Royal Hospital
🇬🇧Chesterfield, England, United Kingdom
Gloucester Royal NHS Trust - Glouchester Royal Hospital
🇬🇧Gloucester, England, United Kingdom
Wharfdale General Hospital
🇬🇧Otley, England, United Kingdom
St Helier Hospital
🇬🇧Carshalton, England, United Kingdom
Harrogate District Hospital
🇬🇧Harrogate, England, United Kingdom
Walton General Hospital
🇬🇧Liverpool, England, United Kingdom
Royal Free and University College Medical School
🇬🇧London, England, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, England, United Kingdom
Bradford Hospitals NHS Trust
🇬🇧Bradford, England, United Kingdom
Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Saint Richards Hospital
🇬🇧Chichester, England, United Kingdom
Darlington Memorial
🇬🇧Darlington, England, United Kingdom
Institute of Oncology and Radiology of Serbia
🇬🇧High Wycombe, England, United Kingdom
Huddersfield Royal Infirmary
🇬🇧Huddersfield, West Yorks, England, United Kingdom
Clinical Trials and Research Unit of the University of Leeds
🇬🇧Leeds, England, United Kingdom
Royal Liverpool and Broadgreen Hospitals
🇬🇧Liverpool, England, United Kingdom
Oldchurch Hospital
🇬🇧Romford, England, United Kingdom
Conquest Hospital
🇬🇧Saint Leonards-on-Sea, England, United Kingdom
Scunthorpe General Hospital
🇬🇧Scunthorpe, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Belfast City Hospital Trust
🇬🇧Belfast, Northern Ireland, United Kingdom
Ysbyty Gwynedd
🇬🇧Bangor, Wales, United Kingdom
Torbay Hospital
🇬🇧Torquay Devon, England, United Kingdom