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

Lymphoma Clinical Trial

Official title:

Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00006250
• Other study ID #: CDR0000068182
• Secondary ID: BNLI-MCD/FMDEU-2
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 11, 2000
• Last updated: September 19, 2013
• Start date: May 2000

Study information

• Verified date: March 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• chlorambucil

• dexamethasone

• fludarabine phosphate

• mitoxantrone hydrochloride

Locations

Country	Name	City	State
United Kingdom	Stoke Mandeville Hospital	Aylesbury-Buckinghamshire	England
United Kingdom	Ysbyty Gwynedd	Bangor	Wales
United Kingdom	Basildon University Hospital	Basildon	England
United Kingdom	Centre for Cancer Research and Cell Biology at Belfast City Hospital	Belfast	Northern Ireland
United Kingdom	Birmingham Heartlands Hospital	Birmingham	England
United Kingdom	Bradford Hospitals NHS Trust	Bradford	England
United Kingdom	Kent and Canterbury Hospital	Canterbury	England
United Kingdom	University Hospital of Wales	Cardiff	Wales
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	St Helier Hospital	Carshalton	England
United Kingdom	Saint Richards Hospital	Chichester	England
United Kingdom	Walsgrave Hospital	Coventry	England
United Kingdom	Craigavon Area Hospital	Craigavon	Northern Ireland
United Kingdom	Dartford & Gravesham NHS Trust, Joyce Green Hospital	Dartford Kent	England
United Kingdom	Derbyshire Royal Infirmary	Derby	England
United Kingdom	Doncaster Royal Infirmary	Doncaster	England
United Kingdom	Russells Hall Hospital	Dudley	England
United Kingdom	Ulster Hospital	Dundonald	Northern Ireland
United Kingdom	Epsom General Hospital	Epsom Surrey	England
United Kingdom	Northwick Park Hospital	Harrow	England
United Kingdom	Wycombe General Hospital	High Wycombe	England
United Kingdom	Huddersfield Royal Infirmary	Huddersfield, West Yorks	England
United Kingdom	Hull Royal Infirmary	Hull	England
United Kingdom	Ipswich Hospital NHS Trust	Ipswich	England
United Kingdom	West Middlesex University Hospital	Isleworth	England
United Kingdom	Kettering General Hosptial	Kettering, Northants	England
United Kingdom	Queen Elizabeth Hospital	King's Lynn	England
United Kingdom	Clinical Trials and Research Unit of the University of Leeds	Leeds	England
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Aintree University Hospital	Liverpool	England
United Kingdom	Great Ormond Street Hospital for Children NHS Trust	London	England
United Kingdom	St. Georges, University of London	London	England
United Kingdom	St. Thomas' Hospital	London	England
United Kingdom	University College of London Hospitals	London	England
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England
United Kingdom	Derriford Hospital	Plymouth	England
United Kingdom	Pontefract General Infirmary	Pontefract West Yorkshire	England
United Kingdom	Glan Clywd District General Hospital	Rhyl, Denbighshire	Wales
United Kingdom	Oldchurch Hospital	Romford	England
United Kingdom	Rotherham District General Hospital - NHS Trust	Rotherham	England
United Kingdom	Pembury Hospital	Royal Tunbridge Wells, Kent	England
United Kingdom	Scunthorpe General Hospital	Scunthorpe	England
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England
United Kingdom	Royal Hallamshire Hospital	Sheffield	England
United Kingdom	Staffordshire General Hospital	Stafford	England
United Kingdom	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England
United Kingdom	Singleton Hospital of the Swansea NHS Trust	Swansea	Wales
United Kingdom	Taunton and Somerset Hospital	Taunton Somerset	England
United Kingdom	Torbay Hospital	Torquay Devon	England
United Kingdom	Hillingdon Hospital	Uxbridge	England
United Kingdom	Pinderfields Hospital NHS Trust	Wakefield	Scotland
United Kingdom	Sandwell General Hospital	West Bromwich	England
United Kingdom	Good Hope Hospital Trust	West Midlands	England
United Kingdom	New Cross Hospital	Wolverhampton	England
United Kingdom	Worthing Hospital	Worthing	England
United Kingdom	Yeovil District Hospital	Yeovil - Somerset	England
United Kingdom	Cancer Care Centre at York Hospital	York	England

Sponsors (1)

Lead Sponsor	Collaborator
Lymphoma Trials Office

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to treatment failure			No
Primary	Progression-free survival rate			No
Primary	Overall survival rate			No
Secondary	Clinical remission rate			No
Secondary	Molecular remission rate			No