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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006250
First received: September 11, 2000
Last updated: September 19, 2013
Last verified: March 2007
  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 Intervention Phase
Lymphoma
Drug: chlorambucil
Drug: dexamethasone
Drug: fludarabine phosphate
Drug: mitoxantrone hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to treatment failure [ Designated as safety issue: No ]
  • Progression-free survival rate [ Designated as safety issue: No ]
  • Overall survival rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical remission rate [ Designated as safety issue: No ]
  • Molecular remission rate [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: May 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006250

  Hide Study Locations
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
University College of London Hospitals
London, England, United Kingdom, WIT 3AA
Great Ormond Street Hospital for Children NHS Trust
London, England, United Kingdom, WC1N 3JH
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
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Royal Hallamshire Hospital
Sheffield, England, United Kingdom, S1O 2JF
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
Investigators
Study Chair: Andy Haynes, MD Nottingham City Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006250     History of Changes
Other Study ID Numbers: CDR0000068182, BNLI-MCD/FMD, EU-20035
Study First Received: September 11, 2000
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

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
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Fludarabine
Fludarabine phosphate
Mitoxantrone
Chlorambucil
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on September 16, 2014