Not Signed In -
Chlorambucil |
Leukeran |
Clinical Trial: Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma
This study is currently recruiting patients.
Purpose
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 chemotherapy regimen is more effective for non-Hodgkin's lymphoma.
PURPOSE: Randomized phase 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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma | Drug: chlorambucil Drug: dexamethasone Drug: fludarabine Drug: mitoxantrone Procedure: chemotherapy | Phase III |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Lymphatic Diseases; Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Chlorambucil, Mitoxantrone, and Dexamethasone Versus Fludarabine, Mitoxantrone, and Dexamethasone in Patients With Newly Diagnosed Stage III or IV Follicular Non-Hodgkin's Lymphoma
Further Study 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
Ages Eligible for Study: 18 Years - 70 Years, Genders Eligible for Study: Both
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
Location and Contact Information
United Kingdom, England
Aintree University Hospital, Liverpool, England, L9 7AL, United Kingdom; Recruiting
A. Olujohungbe, MD 44-1515-292-837 aolujohungbe@btclick.com
Basildon University Hospital, Basildon, England, SS16 5NL, United Kingdom; Recruiting
Paul Cervi, MD 44-1268-593-018
Birmingham Heartlands and Solihull NHS Trust -Teaching, Birmingham, England, B9 5SS, United Kingdom; Recruiting
C. Fegan, MD 44-1217-666-611
Bradford Hospitals NHS Trust, Bradford, England, BD9 6RJ, United Kingdom; Recruiting
J Newton, MD 44-1274-542-200
Cancer Care Centre at York Hospital, York, England, Y031 8HE, United Kingdom; Recruiting
M. Howard, MD 44-190-431-313 martin.r.Howard@york.nhs.uk
Cancer Research Centre at Weston Park Hospital, Sheffield, England, S1O 2SJ, United Kingdom; Recruiting
B.W. Hancock, MD 44-114-226-5000 b.w.hancock@sheffield.ac.uk
Dartford & Gravesham NHS Trust, Joyce Green Hospital, Dartford Kent, England, DA1 5PL, United Kingdom; Recruiting
Vivienne E. Andrews, MD 44-1322-428-100
Derbyshire Royal Infirmary, Derby, England, DE1 2QY, United Kingdom; Recruiting
D.C. Mitchell, MD 44-0133-347-141
Derriford Hospital, Plymouth, England, PL6 8DH, United Kingdom; Recruiting
Archibald G. Prentice, MB, FRCP, FRCPath 44-1752-792-398 achie.prentice@phnt.swest.nhs.uk
Doncaster Royal Infirmary, Doncaster, England, DN2 5LT, United Kingdom; Recruiting
Paul 44-1302-366-666
Epsom General Hospital, Epsom Surrey, England, KT18 7E9, United Kingdom; Recruiting
Lydia Jones, MD, BSc, BS, FRCP, FRCPath 44-1372-735-735 lydia.jones@epsom-sthelier.nhs.uk
Good Hope Hospital Trust, West Midlands, England, B75 7RR, United Kingdom; Recruiting
Malcolm S. Hamilton, MD 0121-378-2211 ext. 2202 malcolm.hamilton@goodhope.nhs.uk
Great Ormond Street Hospital for Children NHS Trust, London, England, WC1N 3JH, United Kingdom; Recruiting
David K.H. Webb 44-20-7405-9200
Guy's and St. Thomas' Hospitals NHS Foundation Trust, London, England, SE1 9RT, United Kingdom; Recruiting
Stephen Schey, MD 44-207-955-5000
Hillingdon Hospital, Uxbridge, England, UB8 3NN, United Kingdom; Recruiting
Jan-Mohammed, MD 44-0189-238-282 rmijanmohammed@hotmail.com
Huddersfield Royal Infirmary, Huddersfield, West Yorks, England, HD3 3EA, United Kingdom; Recruiting
Contact Person 44-1484-342-000
Hull Royal Infirmary, Hull, England, HU3 2KZ, United Kingdom; Recruiting
R.L. Shields, MD 44-1482-674-542
Ipswich Hospital NHS Trust, Ipswich, England, IP4 5PD, United Kingdom; Recruiting
J. S. Morgan, MD, FRCR, MRCP 44-1473-712-233 jamie.morgan@ipswichhospital.nhs.uk
Kent and Canterbury Hospital, Canterbury, England, CT2 7NR, United Kingdom; Recruiting
R. S. Coltart 44-122-766-877
Kettering General Hosptial, Kettering, Northants, England, NNI6 8UZ, United Kingdom; Recruiting
M. Lyttelton, MD 44-1536-492-698 matthew.lyttelton@kgh.nks.uk
Leeds General Infirmary at Leeds Teaching Hospital NHS Trust, Leeds, England, LS1 3EX, United Kingdom; Recruiting
J. A. Child, MD 44-1132-432-799 tony.child@leedsth.nhs.uk
Leicester Royal Infirmary, Leicester, England, LE1 5WW, United Kingdom; Recruiting
James 44-116-254-1414
Meyerstein Institute of Oncology at University College of London Hospitals, London, England, WIT 3AA, United Kingdom; Recruiting
Ryan 44-20-743-6646
Mount Vernon Hospital, Northwood, England, HA6 2RN, United Kingdom; Recruiting
Disa 44-1923-826-111
New Cross Hospital, Wolverhampton, England, WV10 0QP, United Kingdom; Recruiting
Jacob 44-1902-307-999
Northwick Park Hospital, Harrow, England, HA1 3UJ, United Kingdom; Recruiting
C. Reid, MD 44-20-8864-3232 haem.nph@dial.pipex.com
Nottingham City Hospital NHS Trust, Nottingham, England, NG5 1PB, United Kingdom; Recruiting
Eric Michael Bessell, MD, PhD, FRCP, FRCR 44-115-969-1169 ebessell@ncht.trent.nhs.uk
Oldchurch Hospital, Romford, England, RM7 OBE, United Kingdom; Recruiting
Alison Brownell, MD 44-0170-345-533
Pembury Hospital, Royal Tunbridge Wells, Kent, England, TN2 4QJ, United Kingdom; Recruiting
D.S. Gillett, FRCP, FRCPath 44-1892-823-535
Pontefract General Infirmary, Pontefract West Yorkshire, England, WF8 1PL, United Kingdom; Recruiting
D. Wright, MD 44-1977-600-600
Queen Elizabeth Hospital, King's Lynn, England, PE30 4ET, United Kingdom; Recruiting
A. J. Keidan 44-0155-613-613
Rotherham District General Hospital - NHS Trust, Rotherham, England, S60 2UD, United Kingdom; Recruiting
Peter Taylor 44-1709-307-119 peter.taylor@rothgen.nhs.uk
Royal Hallamshire Hospital, Sheffield, England, S1O 2JF, United Kingdom; Recruiting
J. Wright 44-1142-712-030
Royal Marsden NHS Foundation Trust - Surrey, Sutton, England, SM2 5PT, United Kingdom; Recruiting
David Cunningham, MD 44-20-864-2601 dcunn@ar.ac.uk
Russells Hall Hospital, Dudley, England, DY1 2HQ, United Kingdom; Recruiting
J. R. Neilson 44-1384-45-6111
Saint Richards Hospital, Chichester, England, P019 4SE, United Kingdom; Recruiting
P.C. Bevan 44-1243-788-122
Sandwell General Hospital, West Bromwich, England, B71 4HJ, United Kingdom; Recruiting
Penny J. Stableforth, MD 44-121-553-1831
Scunthorpe General Hospital, Scunthorpe, England, DN15 7BH, United Kingdom; Recruiting
S. Jalihal, MD 44-1724-282-282 Sanjeev.Jalihal@nlg.nhs.uk
St Helier Hospital, Carshalton, England, SM5 1AA, United Kingdom; Recruiting
J Mercieca, MD 44-20-8646-1747
St. Georges Hospital Medical School, London, England, SW17 ORE, United Kingdom; Recruiting
Ruth Pettengell, MD 44-20-8672-1255 r.petteng@sghms.ac.uk
St. James's University Hospital at Leeds Teaching Hospital NHS Trust, Leeds, England, LS9 7TF, United Kingdom; Recruiting
P. Johnson 44-1132-064-904
Staffordshire General Hospital, Stafford, England, ST16 3SA, United Kingdom; Recruiting
Paul Revell, MD 44-1785-257-731 jayne.anslow@msgh-tr.wmids.nhs.uk
Stoke Mandeville Hospital, Aylesbury-Buckinghamshire, England, HP21 8AL, United Kingdom; Recruiting
A.M. O'Hea, MD 44-1-296-315-000
Taunton and Somerset Hospital, Taunton Somerset, England, TA1 5DA, United Kingdom; Recruiting
Stephen Johnson, MD 441-823-342-269 steve.johnson@tst.nhs.uk
Torbay Hospital, Torquay Devon, England, TQ2 7AA, United Kingdom; Recruiting
S.R. Smith, MD 44-180-614-567
Walsgrave Hospital, Coventry, England, CV2 2DX, United Kingdom; Recruiting
B. Harrison 44-24-766-0202
West Middlesex Hospital, Middlesex, England, N18 1QZ, United Kingdom; Recruiting
M. Sekhar, MD 44-208-321-5716 mallika.sekhar@wmuh-tr.nthames.nhs.uk
Worthing Hospital, Worthing, England, BN11 2DH, United Kingdom; Recruiting
A. O'Driscolla 44-1903-20-5111
Wycombe General Hospital, High Wycombe, England, United Kingdom; Recruiting
J. Pattinson 44-1494-526-161
Yeovil District Hospital, Yeovil - Somerset, England, BA21 4AT, United Kingdom; Recruiting
Alan J. Davies 44-1935-475-122
United Kingdom, Northern Ireland
Belfast City Hospital Trust, Belfast, Northern Ireland, BT9 7AB, United Kingdom; Recruiting
Kettle 44-0-28-9032-9241 paul.kettle@bll.n-i.nhs.uk
Craigavon Area Hospital, Craigavon, Northern Ireland, BT63 5QQ, United Kingdom; Recruiting
H. Kathryn Boyd, MD 44-28-3833-4444
Ulster Hospital, Dundonald, Northern Ireland, BT16, United Kingdom; Recruiting
K. Bailie 44-28-9048-4511
United Kingdom, Scotland
Pinderfields Hospital NHS Trust, Wakefield, Scotland, WF1 4DG, United Kingdom; Recruiting
P. Hillmen, MD 44-0192-201-688 peter.hillmen@panp-tr.northy.nhs.uk
United Kingdom, Wales
Glan Clywd District General Hospital, Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom; Recruiting
Christine Hoyle 44-174-5534-391 christine.hoyle@cd-tr.wales.nhs.uk
Singleton Hospital, Swansea, Wales, SA 2 8QA, United Kingdom; Recruiting
Saad Al-Ismail, MD 44-1792-285-299 saad.al-ismail@swansea-tr.wales.nhs.uk
University Hospital of Wales, Cardiff, Wales, CF14 4XN, United Kingdom; Recruiting
C.H. Poynton, MD 44-292-0747-747 poynton@cardiff.ac.uk
Velindre Cancer Center at Velinde Hospital, Cardiff, Wales, CF14 2TL, United Kingdom; Recruiting
Timothy Maughan, MD 44-29-206-1588
Ysbyty Gwynedd, Bangor, Wales, LL57 2PW, United Kingdom; Recruiting
H. Parry, MD 44-1248-384-384
Study chairs or principal investigators
Andy Haynes, MD, Study Chair, Nottingham City Hospital NHS Trust
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000068182; BNLI-MCD/FMD; EU-20035; NCT00006250
Record last reviewed: September 2000
Last Updated: March 28, 2005
Record first received: September 11, 2000
ClinicalTrials.gov Identifier: NCT00006250
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: September 2000
Last Updated: March 28, 2005
Record first received: September 11, 2000
ClinicalTrials.gov Identifier: NCT00006250
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Chlorambucil (Drug Digest)
- Leukeran (Drug Digest)
email this page
print this page
bookmark this page
feedback on this page
