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

NCT00006250 | Unknown Phase 3

• 3 other identifiers: CDR0000068182BNLI-MCD/FMDEU-20035
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 59

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Time to treatment failure

• Progression-free survival rate

• Overall survival rate

Secondary Outcomes (2)

• Clinical remission rate

• Molecular remission rate

Interventions

chlorambucil DRUG

dexamethasone DRUG

fludarabine phosphate DRUG

mitoxantrone hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Lymphoma Trials Office: lead

Study Sites (59)

Stoke Mandeville Hospital

Aylesbury-Buckinghamshire, England, HP21 8AL, United Kingdom

Location

Basildon University Hospital

Basildon, England, SS16 5NL, United Kingdom

Location

Birmingham Heartlands Hospital

Birmingham, England, B9 5SS, United Kingdom

Location

Bradford Hospitals NHS Trust

Bradford, England, BD9 6RJ, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT2 7NR, United Kingdom

Location

St Helier Hospital

Carshalton, England, SM5 1AA, United Kingdom

Location

Saint Richards Hospital

Chichester, England, P019 4SE, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Dartford & Gravesham NHS Trust, Joyce Green Hospital

Dartford Kent, England, DA1 5PL, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Doncaster Royal Infirmary

Doncaster, England, DN2 5LT, United Kingdom

Location

Russells Hall Hospital

Dudley, England, DY1 2HQ, United Kingdom

Location

Epsom General Hospital

Epsom Surrey, England, KT18 7E9, United Kingdom

Location

Northwick Park Hospital

Harrow, England, HA1 3UJ, United Kingdom

Location

Wycombe General Hospital

High Wycombe, England, United Kingdom

Location

Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, HD3 3EA, United Kingdom

Location

Hull Royal Infirmary

Hull, England, HU3 2KZ, United Kingdom

Location

Ipswich Hospital NHS Trust

Ipswich, England, IP4 5PD, United Kingdom

Location

West Middlesex University Hospital

Isleworth, England, TW7 6AF, United Kingdom

Location

Kettering General Hosptial

Kettering, Northants, England, NNI6 8UZ, United Kingdom

Location

Queen Elizabeth Hospital

Kings Lynn, England, PE30 4ET, United Kingdom

Location

Clinical Trials and Research Unit of the University of Leeds

Leeds, England, LS2 9N9, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Aintree University Hospital

Liverpool, England, L9 7AL, United Kingdom

Location

St. Thomas' Hospital

London, England, SE1 7EH, United Kingdom

Location

St. Georges, University of London

London, England, SW17 ORE, United Kingdom

Location

Great Ormond Street Hospital for Children NHS Trust

London, England, WC1N 3JH, United Kingdom

Location

University College of London Hospitals

London, England, WIT 3AA, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

Location

Pontefract General Infirmary

Pontefract West Yorkshire, England, WF8 1PL, United Kingdom

Location

Oldchurch Hospital

Romford, England, RM7 OBE, United Kingdom

Location

Rotherham District General Hospital - NHS Trust

Rotherham, England, S60 2UD, United Kingdom

Location

Pembury Hospital

Royal Tunbridge Wells, Kent, England, TN2 4QJ, United Kingdom

Location

Scunthorpe General Hospital

Scunthorpe, England, DN15 7BH, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, England, S1O 2JF, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Staffordshire General Hospital

Stafford, England, ST16 3SA, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Taunton and Somerset Hospital

Taunton Somerset, England, TA1 5DA, United Kingdom

Location

Torbay Hospital

Torquay Devon, England, TQ2 7AA, United Kingdom

Location

Hillingdon Hospital

Uxbridge, England, UB8 3NN, United Kingdom

Location

Sandwell General Hospital

West Bromwich, England, B71 4HJ, United Kingdom

Location

Good Hope Hospital Trust

West Midlands, England, B75 7RR, United Kingdom

Location

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

Location

Worthing Hospital

Worthing, England, BN11 2DH, United Kingdom

Location

Yeovil District Hospital

Yeovil - Somerset, England, BA21 4AT, United Kingdom

Location

Cancer Care Centre at York Hospital

York, England, Y031 8HE, United Kingdom

Location

Centre for Cancer Research and Cell Biology at Belfast City Hospital

Belfast, Northern Ireland, BT9 7AB, United Kingdom

Location

Craigavon Area Hospital

Craigavon, Northern Ireland, BT63 5QQ, United Kingdom

Location

Ulster Hospital

Dundonald, Northern Ireland, BT16, United Kingdom

Location

Pinderfields Hospital NHS Trust

Wakefield, Scotland, WF1 4DG, United Kingdom

Location

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

University Hospital of Wales

Cardiff, Wales, CF14 4XN, United Kingdom

Location

Glan Clywd District General Hospital

Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom

Location

Singleton Hospital of the Swansea NHS Trust

Swansea, Wales, SA2 8QA, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular

Interventions

Chlorambucil; Dexamethasone; fludarabine phosphate; Mitoxantrone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Quinones

Study Officials

• Andy Haynes, MD

  Nottingham City Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2000
• First Posted: January 27, 2003
• Study Start: May 1, 2000
• Last Updated: September 20, 2013

Record last verified: 2007-03

Locations

GB (59)