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

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
chlorambucil
dexamethasone
fludarabine phosphate
mitoxantrone hydrochloride
Sponsored by
Lymphoma Trials Office
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stoke Mandeville Hospital
  • Basildon University Hospital
  • Birmingham Heartlands Hospital
  • Bradford Hospitals NHS Trust
  • Kent and Canterbury Hospital
  • St Helier Hospital
  • Saint Richards Hospital
  • Walsgrave Hospital
  • Dartford & Gravesham NHS Trust, Joyce Green Hospital
  • Derbyshire Royal Infirmary
  • Doncaster Royal Infirmary
  • Russells Hall Hospital
  • Epsom General Hospital
  • Northwick Park Hospital
  • Wycombe General Hospital
  • Huddersfield Royal Infirmary
  • Hull Royal Infirmary
  • Ipswich Hospital NHS Trust
  • West Middlesex University Hospital
  • Kettering General Hosptial
  • Queen Elizabeth Hospital
  • Clinical Trials and Research Unit of the University of Leeds
  • Leeds Cancer Centre at St. James's University Hospital
  • Leicester Royal Infirmary
  • Aintree University Hospital
  • St. Thomas' Hospital
  • St. Georges, University of London
  • Great Ormond Street Hospital for Children NHS Trust
  • University College of London Hospitals
  • Mount Vernon Cancer Centre at Mount Vernon Hospital
  • Nottingham City Hospital NHS Trust
  • Derriford Hospital
  • Pontefract General Infirmary
  • Oldchurch Hospital
  • Rotherham District General Hospital - NHS Trust
  • Pembury Hospital
  • Scunthorpe General Hospital
  • Royal Hallamshire Hospital
  • Cancer Research Centre at Weston Park Hospital
  • Staffordshire General Hospital
  • Royal Marsden NHS Foundation Trust - Surrey
  • Taunton and Somerset Hospital
  • Torbay Hospital
  • Hillingdon Hospital
  • Sandwell General Hospital
  • Good Hope Hospital Trust
  • New Cross Hospital
  • Worthing Hospital
  • Yeovil District Hospital
  • Cancer Care Centre at York Hospital
  • Centre for Cancer Research and Cell Biology at Belfast City Hospital
  • Craigavon Area Hospital
  • Ulster Hospital
  • Pinderfields Hospital NHS Trust
  • Ysbyty Gwynedd
  • Velindre Cancer Center at Velindre Hospital
  • University Hospital of Wales
  • Glan Clywd District General Hospital
  • Singleton Hospital of the Swansea NHS Trust

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical remission rate
Molecular remission rate

Full Information

First Posted
September 11, 2000
Last Updated
September 19, 2013
Sponsor
Lymphoma Trials Office
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1. Study Identification

Unique Protocol Identification Number
NCT00006250
Brief Title
Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma
Official Title
Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Lymphoma Trials Office

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
chlorambucil
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate
Intervention Type
Drug
Intervention Name(s)
mitoxantrone hydrochloride
Primary Outcome Measure Information:
Title
Time to treatment failure
Title
Progression-free survival rate
Title
Overall survival rate
Secondary Outcome Measure Information:
Title
Clinical remission rate
Title
Molecular remission rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andy Haynes, MD
Organizational Affiliation
Nottingham City Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Stoke Mandeville Hospital
City
Aylesbury-Buckinghamshire
State/Province
England
ZIP/Postal Code
HP21 8AL
Country
United Kingdom
Facility Name
Basildon University Hospital
City
Basildon
State/Province
England
ZIP/Postal Code
SS16 5NL
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Bradford Hospitals NHS Trust
City
Bradford
State/Province
England
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Kent and Canterbury Hospital
City
Canterbury
State/Province
England
ZIP/Postal Code
CT2 7NR
Country
United Kingdom
Facility Name
St Helier Hospital
City
Carshalton
State/Province
England
ZIP/Postal Code
SM5 1AA
Country
United Kingdom
Facility Name
Saint Richards Hospital
City
Chichester
State/Province
England
ZIP/Postal Code
P019 4SE
Country
United Kingdom
Facility Name
Walsgrave Hospital
City
Coventry
State/Province
England
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Dartford & Gravesham NHS Trust, Joyce Green Hospital
City
Dartford Kent
State/Province
England
ZIP/Postal Code
DA1 5PL
Country
United Kingdom
Facility Name
Derbyshire Royal Infirmary
City
Derby
State/Province
England
ZIP/Postal Code
DE1 2QY
Country
United Kingdom
Facility Name
Doncaster Royal Infirmary
City
Doncaster
State/Province
England
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Facility Name
Russells Hall Hospital
City
Dudley
State/Province
England
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Epsom General Hospital
City
Epsom Surrey
State/Province
England
ZIP/Postal Code
KT18 7E9
Country
United Kingdom
Facility Name
Northwick Park Hospital
City
Harrow
State/Province
England
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Wycombe General Hospital
City
High Wycombe
State/Province
England
Country
United Kingdom
Facility Name
Huddersfield Royal Infirmary
City
Huddersfield, West Yorks
State/Province
England
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
State/Province
England
ZIP/Postal Code
HU3 2KZ
Country
United Kingdom
Facility Name
Ipswich Hospital NHS Trust
City
Ipswich
State/Province
England
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
West Middlesex University Hospital
City
Isleworth
State/Province
England
ZIP/Postal Code
TW7 6AF
Country
United Kingdom
Facility Name
Kettering General Hosptial
City
Kettering, Northants
State/Province
England
ZIP/Postal Code
NNI6 8UZ
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
King's Lynn
State/Province
England
ZIP/Postal Code
PE30 4ET
Country
United Kingdom
Facility Name
Clinical Trials and Research Unit of the University of Leeds
City
Leeds
State/Province
England
ZIP/Postal Code
LS2 9N9
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Aintree University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
St. Thomas' Hospital
City
London
State/Province
England
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
St. Georges, University of London
City
London
State/Province
England
ZIP/Postal Code
SW17 ORE
Country
United Kingdom
Facility Name
Great Ormond Street Hospital for Children NHS Trust
City
London
State/Province
England
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Facility Name
University College of London Hospitals
City
London
State/Province
England
ZIP/Postal Code
WIT 3AA
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
State/Province
England
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Pontefract General Infirmary
City
Pontefract West Yorkshire
State/Province
England
ZIP/Postal Code
WF8 1PL
Country
United Kingdom
Facility Name
Oldchurch Hospital
City
Romford
State/Province
England
ZIP/Postal Code
RM7 OBE
Country
United Kingdom
Facility Name
Rotherham District General Hospital - NHS Trust
City
Rotherham
State/Province
England
ZIP/Postal Code
S60 2UD
Country
United Kingdom
Facility Name
Pembury Hospital
City
Royal Tunbridge Wells, Kent
State/Province
England
ZIP/Postal Code
TN2 4QJ
Country
United Kingdom
Facility Name
Scunthorpe General Hospital
City
Scunthorpe
State/Province
England
ZIP/Postal Code
DN15 7BH
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2JF
Country
United Kingdom
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Staffordshire General Hospital
City
Stafford
State/Province
England
ZIP/Postal Code
ST16 3SA
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Taunton and Somerset Hospital
City
Taunton Somerset
State/Province
England
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
Torbay Hospital
City
Torquay Devon
State/Province
England
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Hillingdon Hospital
City
Uxbridge
State/Province
England
ZIP/Postal Code
UB8 3NN
Country
United Kingdom
Facility Name
Sandwell General Hospital
City
West Bromwich
State/Province
England
ZIP/Postal Code
B71 4HJ
Country
United Kingdom
Facility Name
Good Hope Hospital Trust
City
West Midlands
State/Province
England
ZIP/Postal Code
B75 7RR
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
State/Province
England
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Worthing Hospital
City
Worthing
State/Province
England
ZIP/Postal Code
BN11 2DH
Country
United Kingdom
Facility Name
Yeovil District Hospital
City
Yeovil - Somerset
State/Province
England
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Facility Name
Cancer Care Centre at York Hospital
City
York
State/Province
England
ZIP/Postal Code
Y031 8HE
Country
United Kingdom
Facility Name
Centre for Cancer Research and Cell Biology at Belfast City Hospital
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Craigavon Area Hospital
City
Craigavon
State/Province
Northern Ireland
ZIP/Postal Code
BT63 5QQ
Country
United Kingdom
Facility Name
Ulster Hospital
City
Dundonald
State/Province
Northern Ireland
ZIP/Postal Code
BT16
Country
United Kingdom
Facility Name
Pinderfields Hospital NHS Trust
City
Wakefield
State/Province
Scotland
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
Facility Name
Ysbyty Gwynedd
City
Bangor
State/Province
Wales
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
Facility Name
Velindre Cancer Center at Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Facility Name
Glan Clywd District General Hospital
City
Rhyl, Denbighshire
State/Province
Wales
ZIP/Postal Code
LL 18 5UJ
Country
United Kingdom
Facility Name
Singleton Hospital of the Swansea NHS Trust
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA2 8QA
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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