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Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma Clinical research trials and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma. Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma clinical trial. Participants oftentimes recieve the most expert healthcare available for their Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma
Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma
For Condition: stage 4 grade 1 follicular lymphoma,stage 4 grade 2 follicular lymphoma,stage 3 grade 1 follicular lymphoma,stage 3 grade 3 follicular lymphoma,stage 4 grade 3 follicular lymphoma,stage 3 grade 2 follicular 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 combination chemotherapyregimen is more effective for non-Hodgkin's lymphoma. PURPOSE: Randomizedphase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Compare the overall survival rate, progression free survival rate, clinical and molecular remission rates, and time to treatment failure in patients with newly diagnosed stage III or IV follicular non-Hodgkin's lymphoma treated with chlorambucil, mitoxantrone, and dexamethasone versus fludarabine, mitoxantrone, and dexamethasone. - Compare the efficacy and tolerability of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to International Prognostic Index score [low risk (score 1) vs intermediate low risk (score 2) vs intermediate high risk (score 3) vs high risk (score 4 or 5)]. Patients are randomized to one of two treatment arms. - Arm I: Patients receive mitoxantrone IV on day 1, oral chlorambucil on days 1-10, and oral dexamethasone on days 1-5. - Arm II: Patients receive mitoxantrone and dexamethasone as in arm I and fludarabine IV on days 1-3. Treatment continues every 4 weeks for 4-8 courses. Patients are followed at 3, 6, and 12 months, every 6 months for 1 year, and then annually thereafter until clinical relapse. PROJECTED ACCRUAL: A total of 500 patients (250 per arm) will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven newly diagnosed stage III or IV follicular non-Hodgkin's lymphoma - REAL classification grade I, II, or III - Treatment necessity indicated by presence of the following: - B symptoms - Bone marrow failure - Bulky or progressive disease - Compression syndromes - No CNS involvement PATIENT CHARACTERISTICS: Age: - 18 to 70 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - No autoimmune hemolytic anemia or active hemolysis - Direct Coombs' negative Hepatic: - Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN)* - Bilirubin no greater than 2.5 times ULN* NOTE: *Unless attributable to lymphoma Renal: - Creatinine no greater than 2.5 times ULN (unless attributable to lymphoma) Cardiovascular: - No severe cardiac failure - Ejection fraction at least 45% Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for at least 6 months after study - HIV negative - No prior malignancy except carcinoma in situ of the cervix or squamous cell skin cancer - No other serious medical disease that would limit lifespan or ability to tolerate chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - No concurrent systemic corticosteroids Radiotherapy: - Not specified Surgery: - Not specified Other: - No prior therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AndyHaynes, Study Chair, Nottingham City Hospital NHS Trust
Kent and Canterbury Hospital *Recruiting*
Canterbury, England, CT2 7NR
United Kingdom
Recruiting R. Coltart 44-122-766-877
Torbay Hospital *Recruiting*
Torquay Devon, England, TQ2 7AA
United Kingdom
Recruiting S.R. Smith 44-180-614-567
Royal Marsden Hospital - Sutton *Recruiting*
Sutton, England, SM2 5PT
United Kingdom
Recruiting David Cunningham 44-20-864-2601
Aintree University Hospital *Recruiting*
Liverpool, England, L9 7AL
United Kingdom
Recruiting A. Olujohungbe 44-1515-292-837
Oldchurch Hospital *Recruiting*
Romford, England, RM7 OBE
United Kingdom
Recruiting Alison Brownell 44-0170-345-533
Meyerstein Institute of Oncology at Middlesex Hospital *Recruiting*
London, England, WIT 3AA
United Kingdom
Recruiting Ryan 44-20-743-6646
Kettering General Hosptial *Recruiting*
Kettering, Northants, England, NNI6 8UZ
United Kingdom
Recruiting M. Lyttelton 44-1536-492-698
University of Wales College of Medicine *Recruiting*
Cardiff, Wales, CF14 4XN
United Kingdom
Recruiting C.H. Poynton 44-292-0747-747
Queen Elizabeth Hospital *Recruiting*
King's Lynn, England, PE30 4ET
United Kingdom
Recruiting A. Keidan 44-0155-613-613
Doncaster Royal Infirmary *Recruiting*
Doncaster, England, DN2 5LT
United Kingdom
Recruiting Paul 44-1302-366-666
Great Ormond Street Hospital for Children NHS Trust *Recruiting*
London, England, WC1N 3JH
United Kingdom
Recruiting David Webb 44-20-7405-9200
Pontefract General Infirmary *Recruiting*
Pontefract West Yorkshire, England, WF8 1PL
United Kingdom
Recruiting D. Wright 44-1977-600-600
Staffordshire General Hospital *Recruiting*
Stafford, England, ST16 3SA
United Kingdom
Recruiting P. Revell 44-1785-257-731
St. James's University Hospital *Recruiting*
Leeds, England, LS9 7TF
United Kingdom
Recruiting P. Johnson 44-1132-064-904
Taunton and Somerset Hospital *Recruiting*
Taunton Somerset, England, TA1 5DA
United Kingdom
Recruiting Stephen Johnson 441-823-342-269
Epsom General Hospital *Recruiting*
Epsom Surrey, England, KT18 7E9
United Kingdom
Recruiting Lydia Jones 44-1372-735-735
Cancer Care Center at York Hospital *Recruiting*
York, England, Y031 8HE
United Kingdom
Recruiting M. Howard 44-190-431-313
St. Georges Hospital Medical School *Recruiting*
London, England, SW17 ORE
United Kingdom
Recruiting Ruth Pettengell 44-20-8672-1255
New Cross Hospital *Recruiting*
Wolverhampton, England, WV10 0QP
United Kingdom
Recruiting Jacob 44-1902-307-999
West Middlesex Hospital *Recruiting*
Middlesex, England, N18 1QZ
United Kingdom
Recruiting M. Sekhar 44-208-565-5716
Hillingdon Hospital *Recruiting*
Uxbridge, England, UB8 3NN
United Kingdom
Recruiting Jan-Mohammed 44-0189-238-282
Glan Clywd District General Hospital *Recruiting*
Rhyl, Denbighshire, Wales, LL 18 5UJ
United Kingdom
Recruiting Christine Hoyle 44-192-3826-111
Northwick Park Hospital *Recruiting*
Harrow, England, HA1 3UJ
United Kingdom
Recruiting C. Reid 44-20-8864-3232
Wycombe General Hospital *Recruiting*
High Wycombe, England,
United Kingdom
Recruiting J. Pattinson 44-1494-526-161
Yeovil District Hospital *Recruiting*
Yeovil - Somerset, England, BA21 4AT
United Kingdom
Recruiting Alan Davies 44-1935-475-122
Derbyshire Royal Infirmary *Recruiting*
Derby, England, DE1 2QY
United Kingdom
Recruiting D.C. Mitchell 44-0133-347-141
Walsgrave Hospital *Recruiting*
Coventry, England, CV2 2DX
United Kingdom
Recruiting B. Harrison 44-24-766-0202
Pinderfields Hospital NHS Trust *Recruiting*
Wakefield, Scotland, WF1 4DG
United Kingdom
Recruiting P. Hillmen 44-0192-201-688
Velindre Cancer Center at Velinde Hospital *Recruiting*
Cardiff, Wales, CF14 2TL
United Kingdom
Recruiting Timothy Maughan 44-29-206-1588
St Helier Hospital *Recruiting*
Carshalton, England, SM5 1AA
United Kingdom
Recruiting J Mercieca 44-20-8646-1747
Worthing Hospital *Recruiting*
Worthing, England, BN11 2DH
United Kingdom
Recruiting A. O'Driscolla 44-1903-20-5111
Leicester Royal Infirmary *Recruiting*
Leicester, England, LE1 5WW
United Kingdom
Recruiting James 44-116-254-1414
Basildon Hospital *Recruiting*
Basildon, England, SS16 5NL
United Kingdom
Recruiting P. Cervi 44-1268-533-911
Saint Richards Hospital *Recruiting*
Chichester, England, P019 4SE
United Kingdom
Recruiting P.C. Bevan 44-1243-788-122
Guy's and St. Thomas' Hospitals NHS Trust *Recruiting*
London, England, SE1 9RT
United Kingdom
Recruiting Stephen Schey 44-207-955-5000
Stoke Mandeville Hospital *Recruiting*
Aylesbury-Buckinghamshire, England, HP21 8AL
United Kingdom
Recruiting A.M. O'Hea 44-1-296-315-000
Royal Hallamshire Hospital *Recruiting*
Sheffield, England, S1O 2JF
United Kingdom
Recruiting J. Wright 44-1142-712-030
Hull Royal Infirmary *Recruiting*
Hull, England, HU3 2KZ
United Kingdom
Recruiting R.L. Shields 44-1482-674-542
Rotherham District General Hospital - NHS Trust *Recruiting*
Rotherham, England, S60 2UD
United Kingdom
Recruiting Peter Taylor 44-1709-307-119
Ulster Hospital *Recruiting*
Dundonald, Northern Ireland, BT16
United Kingdom
Recruiting K. Bailie 44-28-9048-4511
Singleton Hospital *Recruiting*
Swansea, Wales, SA 2 8QA
United Kingdom
Recruiting S. Al-Ismail 44-1792-285-299
Craigavon Area Hospital *Recruiting*
Craigavon, Northern Ireland, BT63 5QQ
United Kingdom
Recruiting Katherine Boyd 44-28-3833-4444
Birmingham Heartlands and Solihull NHS Trust -Teaching *Recruiting*
Birmingham, England, B9 5SS
United Kingdom
Recruiting C. Fegan 44-1217-666-611
Belfast City Hospital Trust *Recruiting*
Belfast, Northern Ireland, BT9 7AB
United Kingdom
Recruiting Kettle 44-0-28-9032-9241
Good Hope Hospital Trust *Recruiting*
West Midlands, England, B75 7RR
United Kingdom
Recruiting Malcolm Hamilton 0121-378-2211 ext. 2202
Leeds General Infirmary at Leeds Teaching Hospital NHS Trust *Recruiting*
Leeds, England, LS1 3EX
United Kingdom
Recruiting J.A. Child 44-1132-432-799
Derriford Hospital *Recruiting*
Plymouth, England, PL6 8DH
United Kingdom
Recruiting Archibald Prentice 44-0175-777-111
Ipswich Hospital NHS Trust *Recruiting*
Ipswich, England, IP4 5PD
United Kingdom
Recruiting J.S. Morgan 44-1473-712-233
Pembury Hospital *Recruiting*
Royal Tunbridge Wells, Kent, England, TN2 4QJ
United Kingdom
Recruiting D.S. Gillett 44-1892-823-535
Mount Vernon Hospital *Recruiting*
Northwood, England, HA6 2RN
United Kingdom
Recruiting Disa 44-1923-826-111
Russells Hall Hospital *Recruiting*
Dudley, England, DY1 2HQ
United Kingdom
Recruiting J. Neilson 44-1384-45-6111
Ysbyty Gwynedd *Recruiting*
Bangor, Wales, LL57 2PW
United Kingdom
Recruiting H. Parry 44-1248-384-384
Sandwell & West Birminghan NHS Trust *Recruiting*
West Bromwich, England, B71 4HJ
United Kingdom
Recruiting P.J. Stableforth 44 121 5531831
Weston Park Hospital *Recruiting*
Sheffield, England, S1O 2SJ
United Kingdom
Recruiting B.W. Hancock 44-114-226-5000
Nottingham City Hospital NHS Trust *Recruiting*
Nottingham, England, NG5 1PB
United Kingdom
Recruiting Eric Bessell 44-115-969-1169
Dartford & Gravesham NHS Trust, Joyce Green Hospital *Recruiting*
Dartford Kent, England, DA1 5PL
United Kingdom
Recruiting Vivienne Andrews 44-1322-428-100
Huddersfield Royal Infirmary *Recruiting*
Huddersfield, West Yorks, England, HD3 3EA
United Kingdom
Recruiting C. Carter 44-1484-422-191
Scunthorpe General Hospital *Recruiting*
Scunthorpe, England, DN15 7BH
United Kingdom
Recruiting S. Jalihal 44-1724-282-282
Bradford Hospitals NHS Trust *Recruiting*
Bradford, England, BD9 6RJ
United Kingdom
Recruiting J Newton 44-1274-542-200
Additional Information:
Study ID Numbers: CDR0000068182; EU-20035,BNLI-MCD/FMD
Study Start Date:
Record last reviewed: September 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006250
Other Stage 4 Grade 1 Follicular Lymphoma Studies:
1. Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
2. Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
3. Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma
4. Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma
Related Studies:
Other stage 4 grade 1 follicular lymphoma Clinical Trials
Other England Clinical Trials
Other London Clinical Trials
Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma
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