Spots Global Cancer Trial Database for High Dose Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma
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Trial Identification
Brief Title: High Dose Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma
Official Title: A Randomized Trial to Evaluate Early High Dose Therapy and Autologous Bone Marrow Transplantation as Part of Planned Initial Therapy for Poor Risk Intermediate/High Grade NHL
Study ID: NCT00003578
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether high dose chemotherapy plus bone marrow transplantation is more effective than high dose chemotherapy alone for intermediate- or high-grade non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy with or without bone marrow transplantation in treating patients who have intermediate- or high-grade non-Hodgkin's lymphoma.
Detailed Description: OBJECTIVES: I. Assess the value of early intensification with autologous bone marrow transplantation or stem cell support in patients with poor prognosis intermediate or high grade non-Hodgkin's lymphoma. OUTLINE: This is a randomized, multicenter study. Patients are stratified by age (under 50 vs 50 and over), bone marrow involvement (yes vs no), and country. All patients receive cyclophosphamide, doxorubicin, and vincristine on day 1 and prednisone on days 1-5. Courses repeat every 21 days. Patients receive a minimum of 6 courses of treatment in the absence of disease progression and unacceptable toxicity. Arm I: Patients receive carmustine IV over 2 hours on day 1 in week 9 or 10. Etoposide and cytarabine IV are administered over 30 minutes on days 2-5. Melphalan IV is administered over 5 minutes on day 6. Patients receive cryopreserved bone marrow or peripheral blood stem cells on day 7. Arm II: Patients continue conventional therapy. Patients are followed at 8-9 weeks and 6 months. PROJECTED ACCRUAL: This study will accrue 500 patients.
Keywords
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Charles University Hospital, Prague (Praha), , Czech Republic
Aarhus Amtssygehus, Aarhus, , Denmark
Rigshospitalet, Copenhagen, , Denmark
Norwegian Radium Hospital, Oslo, , Norway
Ullevall Hospital, Oslo, , Norway
University of Tromso, Tromso, , Norway
Stoke Mandeville Hospital, Aylesbury-Buckinghamshire, England, United Kingdom
Royal United Hospital, Bath, England, United Kingdom
City Hospital - Birmingham, Birmingham, England, United Kingdom
Birmingham Heartlands and Solihull NHS Trust (Teaching), Birmingham, England, United Kingdom
Southmead Hospital, Bristol, England, United Kingdom
Bristol Haematology and Oncology Centre, Bristol, England, United Kingdom
Queen's Hospital, Burton, Burton-upon-Trent, England, United Kingdom
Kent and Canterbury Hospital, Canterbury, England, United Kingdom
Cheltenham General Hospital, Cheltenham, England, United Kingdom
Countess of Chester Hospital, Chester, England, United Kingdom
Derbyshire Royal Infirmary, Derby, England, United Kingdom
Royal Free Hospital, Hampstead, London, England, United Kingdom
Northwick Park Hospital, Harrow, England, United Kingdom
Huddersfield Royal Infirmary, Huddersfield, West Yorks, England, United Kingdom
Ipswich Hospital NHS Trust, Ipswich, England, United Kingdom
Leeds Teaching Hospital Trust, Leeds, England, United Kingdom
University Hospitals of Leicester, Leicester, England, United Kingdom
Royal Liverpool and Broadgreen Hospitals, Liverpool, England, United Kingdom
Whipps Cross Hospital, London, England, United Kingdom
Saint Bartholomew's Hospital, London, England, United Kingdom
St. Bartholomew's Hospital, London, England, United Kingdom
St. Georges Hospital Medical School, London, England, United Kingdom
University College London Medical School, London, England, United Kingdom
University College London, London, England, United Kingdom
Charing Cross Hospital, London, England, United Kingdom
Middlesex Hospital- Meyerstein Institute, London, England, United Kingdom
Maidstone Hospital, Maidstone, England, United Kingdom
Christie Hospital N.H.S. Trust, Manchester, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust, Merseyside, England, United Kingdom
Southport and Formby District General Hospital, Merseyside, England, United Kingdom
Milton Keynes General Hospital, Milton Keynes, England, United Kingdom
Mount Vernon Hospital, Northwood, England, United Kingdom
Nottingham City Hospital NHS Trust, Nottingham, England, United Kingdom
Oxford Radcliffe Hospital, Oxford, England, United Kingdom
Derriford Hospital, Plymouth, England, United Kingdom
Oldchurch Hospital, Romford, England, United Kingdom
Pembury Hospital, Royal Tunbridge Wells, Kent, England, United Kingdom
Sheffield Teaching Hospitals, Sheffield, England, United Kingdom
Weston Park Hospital, Sheffield, England, United Kingdom
Royal South Hants Hospital, Southampton, England, United Kingdom
Royal Marsden Hospital, Sutton, England, United Kingdom
Torbay Hospital, Torquay Devon, England, United Kingdom
Hillingdon Hospital, Uxbridge, England, United Kingdom
Sandwell District General Hospital, West Bromwich, England, United Kingdom
Good Hope Hospital Trust, West Midlands, England, United Kingdom
Pontefract General Infirmary, West Yorks, England, United Kingdom
New Cross Hospital, Wolverhampton, England, United Kingdom
Belfast City Hospital Trust, Belfast, Northern Ireland, United Kingdom
Altnagelvin Area Hospital, Londonderry, Northern Ireland, United Kingdom
Ysbyty Gwynedd, Bangor, Wales, United Kingdom
Royal Bournemouth Hospital, Bournemouth, , United Kingdom
Law Hospital, Carluke UK, , United Kingdom
Saint Richards Hospital, Chichester, , United Kingdom
Chase Farm Hospital, Enfield, , United Kingdom
Epsom General Hospital, Epsom Surrey, , United Kingdom
Grantham and District Hospital, Grantham, , United Kingdom
King George Hospital, Ilford, Essex, , United Kingdom
Queen Elizabeth Hospital, King's Lynn, , United Kingdom
Walton General Hospital, Liverpool, , United Kingdom
Newham General Hospital, London, , United Kingdom
St. Mary's Hospital, London, , United Kingdom
West Middlesex Hospital, Middlesex, , United Kingdom
East Surrey Hospital, Redhill, , United Kingdom
Rotherham District General Hospital-NHS Trust, Rotherham, , United Kingdom
Scunthorpe General Hospital, Scunthorpe, , United Kingdom
Staffordshire General Hospital, Stafford, , United Kingdom
Contact Details
Name: David C. Linch
Affiliation: University College London Hospitals
Role: STUDY_CHAIR
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