Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
NCT ID: NCT00005867
Last Updated: 2013-06-26
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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COMPLETED
PHASE3
310 participants
INTERVENTIONAL
1998-01-31
2007-08-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying two regimens of combination chemotherapy and comparing how well they work in treating patients with aggressive non-Hodgkin's lymphoma.
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Detailed Description
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* Compare the overall survival, failure free survival, disease specific survival, relapse free survival, and response rate in patients with aggressive non-Hodgkin's lymphoma treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP).
* Compare the early and late toxicities of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
* Arm I: Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1 and vincristine and bleomycin IV on day 8. Treatment continues every 14 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral prednisolone daily on courses 1 and 2 and every other day beginning on course 3 and continuing until the end of treatment.
* Arm II: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, then every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 310 patients (155 per arm) will be accrued for this study over 5 years.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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bleomycin sulfate
CHOP regimen
cyclophosphamide
doxorubicin hydrochloride
etoposide
mitoxantrone hydrochloride
prednisolone
vincristine sulfate
Eligibility Criteria
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Inclusion Criteria
* Histologically proven previously untreated bulky stage IA or stage IB-IV aggressive non-Hodgkin's lymphoma of 1 of the following types:
* Working formulation:
* Follicular large cell
* Diffuse mixed cell
* Diffuse large cell
* Diffuse immunoblastic OR
* REAL classification:
* Diffuse large B-cell
* Peripheral T-cell
* Measurable or evaluable disease
* Good prognosis defined as no more than one of the following:
* Stage III/IV disease
* LDH greater than upper limit of normal
* ECOG/WHO 2-4
* No lymphoblastic or Burkitt's lymphoma
* No CNS involvement
PATIENT CHARACTERISTICS:
Age:
* 18 to 59
Performance status:
* See Disease Characteristics
Life expectancy:
* Not specified
Hematopoietic:
* Hemoglobin at least 10 g/dL
* Neutrophil count at least 2,000/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin, AST, and ALT no greater than 1.5 times upper limit of normal
Renal:
* Creatinine no greater than 1.7 mg/dL
Cardiovascular:
* Ejection fraction at least 50% unless dysfunction attributable to lymphoma
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other concurrent serious uncontrolled medical conditions
* No other prior malignancy except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to more than 35% of hematopoietic sites
* Concurrent consolidation radiotherapy allowed
Surgery:
* Not specified
18 Years
59 Years
ALL
No
Sponsors
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Lymphoma Trials Office
OTHER
Principal Investigators
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Ruth Pettengell, MD
Role: STUDY_CHAIR
St. George's Hospital
Locations
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Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, United Kingdom
Horton Hospital
Banbury, 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
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom
Cheltenham General Hospital
Cheltenham, England, United Kingdom
Countess of Chester Hospital NHS Foundation Trust
Chester, England, United Kingdom
Saint Richards Hospital
Chichester, England, United Kingdom
Essex County Hospital
Colchester, England, United Kingdom
Walsgrave Hospital
Coventry, England, United Kingdom
Russells Hall Hospital
Dudley, England, United Kingdom
Chase Farm Hospital
Enfield, England, United Kingdom
Medway Maritime Hospital
Gillingham Kent, England, United Kingdom
Hull Royal Infirmary
Hull, England, United Kingdom
Hinchingbrooke Hospital
Huntingdon, England, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Royal Liverpool and Broadgreen Hospitals NHS Trust
Liverpool, England, United Kingdom
Aintree University Hospital
Liverpool, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
St. Thomas' Hospital
London, England, United Kingdom
St. George's Hospital
London, England, United Kingdom
Middlesex Hospital
London, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Pontefract General Infirmary
Pontefract West Yorkshire, England, United Kingdom
Oldchurch Hospital
Romford, England, United Kingdom
Scunthorpe General Hospital
Scunthorpe, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Southampton University Hospital NHS Trust
Southampton, England, United Kingdom
University Hospital of North Staffordshire
Stoke-On-Trent Staffs, England, United Kingdom
East Surrey Hospital
Surrey, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom
Sandwell General Hospital
West Bromwich, 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
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Pinderfields Hospital NHS Trust
Wakefield, Scotland, United Kingdom
Ysbyty Gwynedd
Bangor, Wales, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Glan Clywd District General Hospital
Rhyl, Denbighshire, Wales, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Rhyl, Denbighshire, Wales, United Kingdom
Countries
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Other Identifiers
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CDR0000067900
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-99052
Identifier Type: -
Identifier Source: secondary_id
BNLI-CHOPVPMITCEBO-GOODRISK
Identifier Type: -
Identifier Source: org_study_id
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