|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Lymphoma Trials Office |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003578 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: CHOP regimen Drug: carmustine Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide Drug: melphalan Drug: prednisone Drug: vincristine sulfate Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| 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 |
| Estimated Enrollment: | 500 |
| Study Start Date: | January 1993 |
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.
Eligibility| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed intermediate or high grade adult non-Hodgkin's lymphoma: Follicular large cell lymphoma Diffuse mixed cell lymphoma Diffuse large cell lymphoma Diffuse immunoblastic lymphoma Poor prognostic features defined as the presence of 2 or 3 of the following: Stage III/IV Lactase dehydrogenase greater than normal ECOG performance status 2-4 A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS: Age: 16 to 65 Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics Renal: Not specified Other: No other medical condition prohibiting intensive therapy
PRIOR CONCURRENT THERAPY: At least 5 years since prior systemic therapy for cancer
Contacts and Locations
Hide Study Locations| Czech Republic | |
| Charles University Hospital | |
| Prague (Praha), Czech Republic, 128 08 | |
| Denmark | |
| Aarhus Amtssygehus | |
| Aarhus, Denmark, DK 8000 | |
| Rigshospitalet | |
| Copenhagen, Denmark, 2100 | |
| Norway | |
| University of Tromso | |
| Tromso, Norway, N-9037 | |
| Ullevall Hospital | |
| Oslo, Norway, N-0407 4 | |
| Norwegian Radium Hospital | |
| Oslo, Norway, N-0310 | |
| United Kingdom | |
| Chase Farm Hospital | |
| Enfield, United Kingdom, NG31 8DG | |
| East Surrey Hospital | |
| Redhill, United Kingdom, RH1 5RH | |
| Epsom General Hospital | |
| Epsom Surrey, United Kingdom, KT19 7EG | |
| Scunthorpe General Hospital | |
| Scunthorpe, United Kingdom, DN15 7BH | |
| King George Hospital | |
| Ilford, Essex, United Kingdom, IG3 8YB | |
| Law Hospital | |
| Carluke UK, United Kingdom, ML8 5ER | |
| Newham General Hospital | |
| London, United Kingdom, E13 8RU | |
| Queen Elizabeth Hospital | |
| King's Lynn, United Kingdom, PE30 4ET | |
| Rotherham District General Hospital-NHS Trust | |
| Rotherham, United Kingdom, S60 2UD | |
| Royal Bournemouth Hospital | |
| Bournemouth, United Kingdom, BH7 7DW | |
| Saint Richards Hospital | |
| Chichester, United Kingdom, P019 4SE | |
| Grantham and District Hospital | |
| Grantham, United Kingdom, NG31 8DG | |
| St. Mary's Hospital | |
| London, United Kingdom, W2 1NY | |
| Staffordshire General Hospital | |
| Stafford, United Kingdom, ST16 3SA | |
| Walton General Hospital | |
| Liverpool, United Kingdom, L9 1AE | |
| West Middlesex Hospital | |
| Middlesex, United Kingdom, N18 1QZ | |
| United Kingdom, England | |
| Birmingham Heartlands and Solihull NHS Trust (Teaching) | |
| Birmingham, England, United Kingdom, B9 5SS | |
| Bristol Haematology and Oncology Centre | |
| Bristol, England, United Kingdom, BS2 8ED | |
| Charing Cross Hospital | |
| London, England, United Kingdom, W6 8RF | |
| Cheltenham General Hospital | |
| Cheltenham, England, United Kingdom, GL53 7AN | |
| Christie Hospital N.H.S. Trust | |
| Manchester, England, United Kingdom, M20 4BX | |
| Ipswich Hospital NHS Trust | |
| Ipswich, England, United Kingdom, IP4 5PD | |
| Clatterbridge Centre for Oncology NHS Trust | |
| Merseyside, England, United Kingdom, L63 4JY | |
| Countess of Chester Hospital | |
| Chester, England, United Kingdom, CH2 1UL | |
| Derbyshire Royal Infirmary | |
| Derby, England, United Kingdom, DE1 2QY | |
| Derriford Hospital | |
| Plymouth, England, United Kingdom, PL6 8DH | |
| Good Hope Hospital Trust | |
| West Midlands, England, United Kingdom, B75 7RR | |
| Hillingdon Hospital | |
| Uxbridge, England, United Kingdom, UB8 3NN | |
| Huddersfield Royal Infirmary | |
| Huddersfield, West Yorks, England, United Kingdom, HD3 3EA | |
| City Hospital - Birmingham | |
| Birmingham, England, United Kingdom, B18 7QH | |
| Kent and Canterbury Hospital | |
| Canterbury, England, United Kingdom, CT2 7NR | |
| Leeds Teaching Hospital Trust | |
| Leeds, England, United Kingdom, LS1 3EX | |
| Maidstone Hospital | |
| Maidstone, England, United Kingdom, ME16 9QQ | |
| Middlesex Hospital- Meyerstein Institute | |
| London, England, United Kingdom, WIT 3AA | |
| Milton Keynes General Hospital | |
| Milton Keynes, England, United Kingdom, MK6 5LD | |
| Mount Vernon Hospital | |
| Northwood, England, United Kingdom, HA6 2RN | |
| New Cross Hospital | |
| Wolverhampton, England, United Kingdom, WV10 0QP | |
| Northwick Park Hospital | |
| Harrow, England, United Kingdom, HA1 3UJ | |
| Nottingham City Hospital NHS Trust | |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Royal South Hants Hospital | |
| Southampton, England, United Kingdom, SO14 0YG | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Pembury Hospital | |
| Royal Tunbridge Wells, Kent, England, United Kingdom, TN2 4QJ | |
| Pontefract General Infirmary | |
| West Yorks, England, United Kingdom, WF8 1PL | |
| Queen's Hospital, Burton | |
| Burton-upon-Trent, England, United Kingdom, DE14 3QH | |
| Royal Free Hospital | |
| Hampstead, London, England, United Kingdom, NW3 2QG | |
| Royal Liverpool and Broadgreen Hospitals | |
| Liverpool, England, United Kingdom, L7 8XP | |
| Royal Marsden Hospital | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Oldchurch Hospital | |
| Romford, England, United Kingdom, RM7 OBE | |
| Royal United Hospital | |
| Bath, England, United Kingdom, BA1 3NG | |
| Saint Bartholomew's Hospital | |
| London, England, United Kingdom, EC1A 7BE | |
| Sandwell District General Hospital | |
| West Bromwich, England, United Kingdom | |
| Sheffield Teaching Hospitals | |
| Sheffield, England, United Kingdom, S1O 2JF | |
| Southmead Hospital | |
| Bristol, England, United Kingdom, BS10 5NB | |
| Stoke Mandeville Hospital | |
| Aylesbury-Buckinghamshire, England, United Kingdom, HP21 8AL | |
| St. Bartholomew's Hospital | |
| London, England, United Kingdom, EC1A 7BE | |
| St. Georges Hospital Medical School | |
| London, England, United Kingdom, SW17 ORE | |
| Southport and Formby District General Hospital | |
| Merseyside, England, United Kingdom, PR8 6NJ | |
| Torbay Hospital | |
| Torquay Devon, England, United Kingdom, TQ2 7AA | |
| University College London | |
| London, England, United Kingdom, W1W 7EJ | |
| University College London Medical School | |
| London, England, United Kingdom, W1N 8AA | |
| University Hospitals of Leicester | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Whipps Cross Hospital | |
| London, England, United Kingdom, E11 1NR | |
| United Kingdom, Northern Ireland | |
| Altnagelvin Area Hospital | |
| Londonderry, Northern Ireland, United Kingdom, BT47 1SB | |
| Belfast City Hospital Trust | |
| Belfast, Northern Ireland, United Kingdom, BT9 7AB | |
| United Kingdom, Wales | |
| Ysbyty Gwynedd | |
| Bangor, Wales, United Kingdom, LL57 2PW | |
| Study Chair: | David C. Linch | University College London Hospitals |
More Information
| Study ID Numbers: | CDR0000066645, BNLI-LY02, EU-98039 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003578 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III grade 3 follicular lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma |
stage IV grade 3 follicular lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma |
|
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Melphalan Prednisone Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Antibiotics, Antineoplastic Hormones Therapeutic Uses |
Lymphoma Etoposide Alkylating Agents Cytarabine Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Carmustine Vincristine Antimitotic Agents Glucocorticoids Antiviral Agents Immunosuppressive Agents |
