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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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  Other stage 4 grade 1 follicular lymphoma Clinical Trials
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