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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma  Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
For Condition: adult diffuse large cell lymphoma,adult diffuse mixed cell lymphoma,grade 3 follicular lymphoma,adult immunoblastic large cell lymphoma
Status: Recruiting
Sponsor(s): British National Lymphoma Investigation ,
Synopsis: 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 combination chemotherapy is most effective for non-Hodgkin's lymphoma. PURPOSE: Randomizedphase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who have aggressive non-Hodgkin's lymphoma.
Details: OBJECTIVES: - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/59 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RuthPettengell, Study Chair, St. George's Hospital
University College London Medical School *Recruiting*
London, England, WC1E 6HX
United Kingdom
Recruiting David Linch 44-171-380-9724
Aberdeen Royal Infirmary *Recruiting*
Aberdeen, Scotland, AB25 2ZN
United Kingdom
Recruiting Jane Tighe 44-1224-681-818
Bristol Haematology and Oncology Centre *Recruiting*
Bristol, England, BS2 8ED
United Kingdom
Recruiting Christopher Price 44-0117-923-0000
Essex County Hospital *Recruiting*
Colchester, England, C03 3NB
United Kingdom
Recruiting Philip Murray 44-0120-674-7474
Scunthorpe General Hospital *Recruiting*
Scunthorpe, England, DN15 7BH
United Kingdom
Recruiting S. Jalihal 44-1724-282-282
Walsgrave Hospital *Recruiting*
Coventry, England, CV2 2DX
United Kingdom
Recruiting C Orwin 44-024-766-0202
Russells Hall Hospital *Recruiting*
Dudley, England, DY1 2HQ
United Kingdom
Recruiting J. Neilson 44-1384-45-6111
Basildon Hospital *Recruiting*
Basildon, England, SS16 5NL
United Kingdom
Recruiting P. Cervi 44-1268-533-911
East Surrey Hospital *Recruiting*
Surrey, England, RH1 5RH
United Kingdom
Recruiting F. Matthey 44-0173-776-8511
Glan Clywd District General Hospital *Recruiting*
Rhyl, Denbighshire, Wales, LL 18 5UJ
United Kingdom
Recruiting David Edwards 44-017-4558-3910
Royal Marsden Hospital - Sutton *Recruiting*
Sutton, England, SM2 5PT
United Kingdom
Recruiting David Cunningham 44-208-642-6011
Aintree University Hospital *Recruiting*
Liverpool, England, L9 7AL
United Kingdom
Recruiting Barrie Woodcock 44-0151-529-4655
Sandwell & West Birminghan NHS Trust *Recruiting*
West Bromwich, England, B71 4HJ
United Kingdom
Recruiting P.J. Stableforth 44 121 5531831
Mount Vernon Hospital *Recruiting*
Rhyl, Denbighshire, Wales, LL 18 5UJ
United Kingdom
Recruiting Christine Hoyle 44-192-3826-111
Nottingham City Hospital NHS Trust *Recruiting*
Nottingham, England, NG5 1PB
United Kingdom
Recruiting A. McMillan 44-115-969-1169
Pinderfields Hospital NHS Trust *Recruiting*
Wakefield, Scotland, WF1 4DG
United Kingdom
Recruiting P. Hillmen 44-0192-420-1688
Hull Royal Infirmary *Recruiting*
Hull, England, HU3 2KZ
United Kingdom
Recruiting R. Patmore 44-014-8232-8541
Belfast City Hospital Trust *Recruiting*
Belfast, Northern Ireland, BT9 7AB
United Kingdom
Recruiting T.C.M. Morris 44-028-9032-9241
Saint Bartholomew's Hospital *Recruiting*
London, England, EC1A 7BE
United Kingdom
Recruiting Ama Rohatiner 44-20-7601-7463
Countess of Chester Hospital *Recruiting*
Chester, England, CH2 1UL
United Kingdom
Recruiting Elisabeth Rhodes 44-1244-365-000
Guy's and St. Thomas' Hospitals NHS Trust *Recruiting*
London, England, SE1 9RT
United Kingdom
Recruiting Stephen Schey 44-207-955-5000
Hinchingbrooke Hospital *Recruiting*
Huntingdon, England, PE18 6NT
United Kingdom
Recruiting Kanchan Rege 44-014-8041-6416
Norfolk and Norwich University Hospital *Recruiting*
Norwich, England, NR4 7UY
United Kingdom
Recruiting J. Wimperis 44-1603-286-899
Leeds General Infirmary at Leeds Teaching Hospital NHS Trust *Recruiting*
Leeds, England, LS1 3EX
United Kingdom
Recruiting Gareth Morgan 44-113-243-2799
Stoke Mandeville Hospital *Recruiting*
Aylesbury-Buckinghamshire, England, HP21 8AL
United Kingdom
Recruiting A.M. O'Hea 44-1-296-315-000
Addenbrooke's NHS Trust *Recruiting*
Cambridge, England, CB2 2QQ
United Kingdom
Recruiting Robert Marcus 44-1223-217-071
Chase Farm Hospital *Recruiting*
Enfield, England, EN 28 JL
United Kingdom
Recruiting M. Treacy 44-20-8364-5168
Bradford Hospitals NHS Trust *Recruiting*
Bradford, England, BD9 6RJ
United Kingdom
Recruiting J Newton 44-1274-542-200
Oxford Radcliffe Hospital *Recruiting*
Oxford, England, 0X3 9DU
United Kingdom
Recruiting C. Hatton 44-186-522-6180
Weston Park Hospital *Recruiting*
Sheffield, England, S1O 2SJ
United Kingdom
Recruiting B.W. Hancock 44-114-226-5000
Birmingham Heartlands and Solihull NHS Trust -Teaching *Recruiting*
Birmingham, England, B9 5SS
United Kingdom
Recruiting D.W. Milligan 44-0121-424-2000 ext. 43703 an
Clatterbridge Centre for Oncology NHS Trust *Recruiting*
Merseyside, England, CH63 4JY
United Kingdom
Recruiting Peter Clark 44-151-334-1155
Cheltenham General Hospital *Recruiting*
Cheltenham, England, GL53 7AN
United Kingdom
Recruiting Kim Benstead 44-8454-223-510
Pontefract General Infirmary *Recruiting*
Pontefract West Yorkshire, England, WF8 1PL
United Kingdom
Recruiting D. Wright 44-1977-600-600
Cancer Care Center at York Hospital *Recruiting*
York, England, Y031 8HE
United Kingdom
Recruiting M. Howard 44-19-043-1313
Royal Liverpool and Broadgreen Hospitals *Recruiting*
Liverpool, England, L7 8XP
United Kingdom
Recruiting A. Pettit 44-151-706-4363
St. George's Hospital *Recruiting*
London, England, SW17 0QT
United Kingdom
Recruiting Ruth Pettengell 44-20-672-1255
Leicester Royal Infirmary *Recruiting*
Leicester, England, LE1 5WW
United Kingdom
Recruiting M. Boyer 44-116-254-1414
Ysbyty Gwynedd *Recruiting*
Bangor, Wales, LL57 2PW
United Kingdom
Recruiting J C Searle 44-01-4838-4384
North Staffs Royal Infirmary *Recruiting*
Stoke-On-Trent Staffs, England, ST4 6QG
United Kingdom
Recruiting R. Chasty 44-0178-2715-444
Queen Elizabeth Hospital *Recruiting*
King's Lynn, England, PE30 4ET
United Kingdom
Recruiting P. Coates 44-015-5361-3613
Oldchurch Hospital *Recruiting*
Romford, England, RM7 OBE
United Kingdom
Recruiting Alison Brownell 44-0170-345-533
Medway Maritime Hospital *Recruiting*
Gillingham Kent, England, ME7 5NY
United Kingdom
Recruiting M Aldouri 44-0163-483-0000
Saint Richards Hospital *Recruiting*
Chichester, England, P019 4SE
United Kingdom
Recruiting P.C. Bevan 44-1243-788-122
Southampton General Hospital *Recruiting*
Southampton, England, SO16 6YD
United Kingdom
Recruiting Peter Johnson 44-23-8079-6185
Horton Hospital *Recruiting*
Banbury, England, OX16 9AL
United Kingdom
Recruiting W Atoyebi 44-0129-527-5500
University of Wales College of Medicine *Recruiting*
Cardiff, Wales, CF14 4XN
United Kingdom
Recruiting C.H. Poynton 44-29-2074-2654
Additional Information:
Study ID Numbers: CDR0000067900; BNLI-CHOPVPMITCEBO-GOODRISK,EU-99052
Study Start Date:
Record last reviewed: June 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005867
Other Grade 3 Follicular Lymphoma Studies:
1. Combination Chemotherapy and Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
2. Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Gemcitabine in Treating Patients With Previously Untreated Aggressive Non-Hodgkin’s Lymphoma
3. Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder
4. Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
5. Pegfilgrastim in Treating Neutropenia After Chemotherapy in Patients With Mantle Cell or Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Related Studies:
Other grade 3 follicular lymphoma Clinical Trials
Other England Clinical Trials
Other York Clinical Trials
Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
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