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

September 19, 2013 updated by: Lymphoma Trials Office

Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to treatment failure
Overall survival rate
Progression-free survival rate

Secondary Outcome Measures

Outcome Measure
Clinical remission rate
Molecular remission rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lymphoma Trials Office

Investigators

  • Study Chair: Andy Haynes, MD, Nottingham City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068182
  • BNLI-MCD/FMD
  • EU-20035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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