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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006250
Recruitment Status : Unknown
Verified March 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: chlorambucil Drug: dexamethasone Drug: fludarabine phosphate Drug: mitoxantrone hydrochloride Phase 3

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma
Study Start Date : May 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Primary Outcome Measures :
  1. Time to treatment failure
  2. Progression-free survival rate
  3. Overall survival rate

Secondary Outcome Measures :
  1. Clinical remission rate
  2. Molecular remission rate

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 70

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • No autoimmune hemolytic anemia or active hemolysis
  • Direct Coombs' negative


  • 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


  • Creatinine no greater than 2.5 times ULN (unless attributable to lymphoma)


  • No severe cardiac failure
  • Ejection fraction at least 45%


  • 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


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • No concurrent systemic corticosteroids


  • Not specified


  • Not specified


  • No prior therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006250

  Hide Study Locations
United Kingdom
Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, United Kingdom, HP21 8AL
Basildon University Hospital
Basildon, England, United Kingdom, SS16 5NL
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom, B9 5SS
Bradford Hospitals NHS Trust
Bradford, England, United Kingdom, BD9 6RJ
Kent and Canterbury Hospital
Canterbury, England, United Kingdom, CT2 7NR
St Helier Hospital
Carshalton, England, United Kingdom, SM5 1AA
Saint Richards Hospital
Chichester, England, United Kingdom, P019 4SE
Walsgrave Hospital
Coventry, England, United Kingdom, CV2 2DX
Dartford & Gravesham NHS Trust, Joyce Green Hospital
Dartford Kent, England, United Kingdom, DA1 5PL
Derbyshire Royal Infirmary
Derby, England, United Kingdom, DE1 2QY
Doncaster Royal Infirmary
Doncaster, England, United Kingdom, DN2 5LT
Russells Hall Hospital
Dudley, England, United Kingdom, DY1 2HQ
Epsom General Hospital
Epsom Surrey, England, United Kingdom, KT18 7E9
Northwick Park Hospital
Harrow, England, United Kingdom, HA1 3UJ
Wycombe General Hospital
High Wycombe, England, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, United Kingdom, HD3 3EA
Hull Royal Infirmary
Hull, England, United Kingdom, HU3 2KZ
Ipswich Hospital NHS Trust
Ipswich, England, United Kingdom, IP4 5PD
West Middlesex University Hospital
Isleworth, England, United Kingdom, TW7 6AF
Kettering General Hosptial
Kettering, Northants, England, United Kingdom, NNI6 8UZ
Queen Elizabeth Hospital
King's Lynn, England, United Kingdom, PE30 4ET
Clinical Trials and Research Unit of the University of Leeds
Leeds, England, United Kingdom, LS2 9N9
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Aintree University Hospital
Liverpool, England, United Kingdom, L9 7AL
St. Thomas' Hospital
London, England, United Kingdom, SE1 7EH
St. Georges, University of London
London, England, United Kingdom, SW17 ORE
Great Ormond Street Hospital for Children NHS Trust
London, England, United Kingdom, WC1N 3JH
University College of London Hospitals
London, England, United Kingdom, WIT 3AA
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Derriford Hospital
Plymouth, England, United Kingdom, PL6 8DH
Pontefract General Infirmary
Pontefract West Yorkshire, England, United Kingdom, WF8 1PL
Oldchurch Hospital
Romford, England, United Kingdom, RM7 OBE
Rotherham District General Hospital - NHS Trust
Rotherham, England, United Kingdom, S60 2UD
Pembury Hospital
Royal Tunbridge Wells, Kent, England, United Kingdom, TN2 4QJ
Scunthorpe General Hospital
Scunthorpe, England, United Kingdom, DN15 7BH
Royal Hallamshire Hospital
Sheffield, England, United Kingdom, S1O 2JF
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Staffordshire General Hospital
Stafford, England, United Kingdom, ST16 3SA
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Taunton and Somerset Hospital
Taunton Somerset, England, United Kingdom, TA1 5DA
Torbay Hospital
Torquay Devon, England, United Kingdom, TQ2 7AA
Hillingdon Hospital
Uxbridge, England, United Kingdom, UB8 3NN
Sandwell General Hospital
West Bromwich, England, United Kingdom, B71 4HJ
Good Hope Hospital Trust
West Midlands, England, United Kingdom, B75 7RR
New Cross Hospital
Wolverhampton, England, United Kingdom, WV10 0QP
Worthing Hospital
Worthing, England, United Kingdom, BN11 2DH
Yeovil District Hospital
Yeovil - Somerset, England, United Kingdom, BA21 4AT
Cancer Care Centre at York Hospital
York, England, United Kingdom, Y031 8HE
Centre for Cancer Research and Cell Biology at Belfast City Hospital
Belfast, Northern Ireland, United Kingdom, BT9 7AB
Craigavon Area Hospital
Craigavon, Northern Ireland, United Kingdom, BT63 5QQ
Ulster Hospital
Dundonald, Northern Ireland, United Kingdom, BT16
Pinderfields Hospital NHS Trust
Wakefield, Scotland, United Kingdom, WF1 4DG
Ysbyty Gwynedd
Bangor, Wales, United Kingdom, LL57 2PW
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom, CF14 2TL
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XN
Glan Clywd District General Hospital
Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
Singleton Hospital of the Swansea NHS Trust
Swansea, Wales, United Kingdom, SA2 8QA
Sponsors and Collaborators
Lymphoma Trials Office
Study Chair: Andy Haynes, MD Nottingham City Hospital Identifier: NCT00006250     History of Changes
Other Study ID Numbers: CDR0000068182
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: March 2007

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Fludarabine phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Sensory System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors