Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma

Last updated: September 19, 2013
Sponsor: Lymphoma Trials Office
Overall Status: Trial Status Unknown

Phase

3

Condition

Lymphoma

Follicular Lymphoma

Treatment

N/A

Clinical Study ID

NCT00006250
CDR0000068182
EU-20035
BNLI-MCD/FMD
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 500
Study Start date:
May 01, 2000
Estimated Completion Date:

Study Description

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.

Connect with a study center

  • Stoke Mandeville Hospital

    Aylesbury-Buckinghamshire, England HP21 8AL
    United Kingdom

    Site Not Available

  • Basildon University Hospital

    Basildon, England SS16 5NL
    United Kingdom

    Site Not Available

  • Birmingham Heartlands Hospital

    Birmingham, England B9 5SS
    United Kingdom

    Site Not Available

  • Bradford Hospitals NHS Trust

    Bradford, England BD9 6RJ
    United Kingdom

    Site Not Available

  • Kent and Canterbury Hospital

    Canterbury, England CT2 7NR
    United Kingdom

    Site Not Available

  • St Helier Hospital

    Carshalton, England SM5 1AA
    United Kingdom

    Site Not Available

  • Saint Richards Hospital

    Chichester, England P019 4SE
    United Kingdom

    Site Not Available

  • Walsgrave Hospital

    Coventry, England CV2 2DX
    United Kingdom

    Site Not Available

  • Dartford & Gravesham NHS Trust, Joyce Green Hospital

    Dartford Kent, England DA1 5PL
    United Kingdom

    Site Not Available

  • Derbyshire Royal Infirmary

    Derby, England DE1 2QY
    United Kingdom

    Site Not Available

  • Doncaster Royal Infirmary

    Doncaster, England DN2 5LT
    United Kingdom

    Site Not Available

  • Russells Hall Hospital

    Dudley, England DY1 2HQ
    United Kingdom

    Site Not Available

  • Epsom General Hospital

    Epsom Surrey, England KT18 7E9
    United Kingdom

    Site Not Available

  • Northwick Park Hospital

    Harrow, England HA1 3UJ
    United Kingdom

    Site Not Available

  • Wycombe General Hospital

    High Wycombe, England
    United Kingdom

    Site Not Available

  • Huddersfield Royal Infirmary

    Huddersfield, West Yorks, England HD3 3EA
    United Kingdom

    Site Not Available

  • Hull Royal Infirmary

    Hull, England HU3 2KZ
    United Kingdom

    Site Not Available

  • Ipswich Hospital NHS Trust

    Ipswich, England IP4 5PD
    United Kingdom

    Site Not Available

  • West Middlesex University Hospital

    Isleworth, England TW7 6AF
    United Kingdom

    Site Not Available

  • Kettering General Hosptial

    Kettering, Northants, England NNI6 8UZ
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital

    King's Lynn, England PE30 4ET
    United Kingdom

    Site Not Available

  • Clinical Trials and Research Unit of the University of Leeds

    Leeds, England LS2 9N9
    United Kingdom

    Site Not Available

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England LS9 7TF
    United Kingdom

    Site Not Available

  • Leicester Royal Infirmary

    Leicester, England LE1 5WW
    United Kingdom

    Site Not Available

  • Aintree University Hospital

    Liverpool, England L9 7AL
    United Kingdom

    Site Not Available

  • Great Ormond Street Hospital for Children NHS Trust

    London, England WC1N 3JH
    United Kingdom

    Site Not Available

  • St. Georges, University of London

    London, England SW17 ORE
    United Kingdom

    Site Not Available

  • St. Thomas' Hospital

    London, England SE1 7EH
    United Kingdom

    Site Not Available

  • University College of London Hospitals

    London, England WIT 3AA
    United Kingdom

    Site Not Available

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England HA6 2RN
    United Kingdom

    Site Not Available

  • Nottingham City Hospital NHS Trust

    Nottingham, England NG5 1PB
    United Kingdom

    Site Not Available

  • Derriford Hospital

    Plymouth, England PL6 8DH
    United Kingdom

    Site Not Available

  • Pontefract General Infirmary

    Pontefract West Yorkshire, England WF8 1PL
    United Kingdom

    Site Not Available

  • Oldchurch Hospital

    Romford, England RM7 OBE
    United Kingdom

    Site Not Available

  • Rotherham District General Hospital - NHS Trust

    Rotherham, England S60 2UD
    United Kingdom

    Site Not Available

  • Pembury Hospital

    Royal Tunbridge Wells, Kent, England TN2 4QJ
    United Kingdom

    Site Not Available

  • Scunthorpe General Hospital

    Scunthorpe, England DN15 7BH
    United Kingdom

    Site Not Available

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England S1O 2SJ
    United Kingdom

    Site Not Available

  • Royal Hallamshire Hospital

    Sheffield, England S1O 2JF
    United Kingdom

    Site Not Available

  • Staffordshire General Hospital

    Stafford, England ST16 3SA
    United Kingdom

    Site Not Available

  • Royal Marsden NHS Foundation Trust - Surrey

    Sutton, England SM2 5PT
    United Kingdom

    Site Not Available

  • Taunton and Somerset Hospital

    Taunton Somerset, England TA1 5DA
    United Kingdom

    Site Not Available

  • Torbay Hospital

    Torquay Devon, England TQ2 7AA
    United Kingdom

    Site Not Available

  • Hillingdon Hospital

    Uxbridge, England UB8 3NN
    United Kingdom

    Site Not Available

  • Sandwell General Hospital

    West Bromwich, England B71 4HJ
    United Kingdom

    Site Not Available

  • Good Hope Hospital Trust

    West Midlands, England B75 7RR
    United Kingdom

    Site Not Available

  • New Cross Hospital

    Wolverhampton, England WV10 0QP
    United Kingdom

    Site Not Available

  • Worthing Hospital

    Worthing, England BN11 2DH
    United Kingdom

    Site Not Available

  • Yeovil District Hospital

    Yeovil - Somerset, England BA21 4AT
    United Kingdom

    Site Not Available

  • Cancer Care Centre at York Hospital

    York, England Y031 8HE
    United Kingdom

    Site Not Available

  • Centre for Cancer Research and Cell Biology at Belfast City Hospital

    Belfast, Northern Ireland BT9 7AB
    United Kingdom

    Site Not Available

  • Craigavon Area Hospital

    Craigavon, Northern Ireland BT63 5QQ
    United Kingdom

    Site Not Available

  • Ulster Hospital

    Dundonald, Northern Ireland BT16
    United Kingdom

    Site Not Available

  • Pinderfields Hospital NHS Trust

    Wakefield, Scotland WF1 4DG
    United Kingdom

    Site Not Available

  • Ysbyty Gwynedd

    Bangor, Wales LL57 2PW
    United Kingdom

    Site Not Available

  • University Hospital of Wales

    Cardiff, Wales CF14 4XN
    United Kingdom

    Site Not Available

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales CF14 2TL
    United Kingdom

    Site Not Available

  • Glan Clywd District General Hospital

    Rhyl, Denbighshire, Wales LL 18 5UJ
    United Kingdom

    Site Not Available

  • Singleton Hospital of the Swansea NHS Trust

    Swansea, Wales SA2 8QA
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.