Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Outcome Measures
Primary Outcome Measures
- Time to treatment failure []
- Progression-free survival rate []
- Overall survival rate []
Secondary Outcome Measures
- Clinical remission rate []
- Molecular remission rate []
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stoke Mandeville Hospital | Aylesbury-Buckinghamshire | England | United Kingdom | HP21 8AL |
| 2 | Basildon University Hospital | Basildon | England | United Kingdom | SS16 5NL |
| 3 | Birmingham Heartlands Hospital | Birmingham | England | United Kingdom | B9 5SS |
| 4 | Bradford Hospitals NHS Trust | Bradford | England | United Kingdom | BD9 6RJ |
| 5 | Kent and Canterbury Hospital | Canterbury | England | United Kingdom | CT2 7NR |
| 6 | St Helier Hospital | Carshalton | England | United Kingdom | SM5 1AA |
| 7 | Saint Richards Hospital | Chichester | England | United Kingdom | P019 4SE |
| 8 | Walsgrave Hospital | Coventry | England | United Kingdom | CV2 2DX |
| 9 | Dartford & Gravesham NHS Trust, Joyce Green Hospital | Dartford Kent | England | United Kingdom | DA1 5PL |
| 10 | Derbyshire Royal Infirmary | Derby | England | United Kingdom | DE1 2QY |
| 11 | Doncaster Royal Infirmary | Doncaster | England | United Kingdom | DN2 5LT |
| 12 | Russells Hall Hospital | Dudley | England | United Kingdom | DY1 2HQ |
| 13 | Epsom General Hospital | Epsom Surrey | England | United Kingdom | KT18 7E9 |
| 14 | Northwick Park Hospital | Harrow | England | United Kingdom | HA1 3UJ |
| 15 | Wycombe General Hospital | High Wycombe | England | United Kingdom | |
| 16 | Huddersfield Royal Infirmary | Huddersfield, West Yorks | England | United Kingdom | HD3 3EA |
| 17 | Hull Royal Infirmary | Hull | England | United Kingdom | HU3 2KZ |
| 18 | Ipswich Hospital NHS Trust | Ipswich | England | United Kingdom | IP4 5PD |
| 19 | West Middlesex University Hospital | Isleworth | England | United Kingdom | TW7 6AF |
| 20 | Kettering General Hosptial | Kettering, Northants | England | United Kingdom | NNI6 8UZ |
| 21 | Queen Elizabeth Hospital | King's Lynn | England | United Kingdom | PE30 4ET |
| 22 | Clinical Trials and Research Unit of the University of Leeds | Leeds | England | United Kingdom | LS2 9N9 |
| 23 | Leeds Cancer Centre at St. James's University Hospital | Leeds | England | United Kingdom | LS9 7TF |
| 24 | Leicester Royal Infirmary | Leicester | England | United Kingdom | LE1 5WW |
| 25 | Aintree University Hospital | Liverpool | England | United Kingdom | L9 7AL |
| 26 | St. Thomas' Hospital | London | England | United Kingdom | SE1 7EH |
| 27 | St. Georges, University of London | London | England | United Kingdom | SW17 ORE |
| 28 | Great Ormond Street Hospital for Children NHS Trust | London | England | United Kingdom | WC1N 3JH |
| 29 | University College of London Hospitals | London | England | United Kingdom | WIT 3AA |
| 30 | Mount Vernon Cancer Centre at Mount Vernon Hospital | Northwood | England | United Kingdom | HA6 2RN |
| 31 | Nottingham City Hospital NHS Trust | Nottingham | England | United Kingdom | NG5 1PB |
| 32 | Derriford Hospital | Plymouth | England | United Kingdom | PL6 8DH |
| 33 | Pontefract General Infirmary | Pontefract West Yorkshire | England | United Kingdom | WF8 1PL |
| 34 | Oldchurch Hospital | Romford | England | United Kingdom | RM7 OBE |
| 35 | Rotherham District General Hospital - NHS Trust | Rotherham | England | United Kingdom | S60 2UD |
| 36 | Pembury Hospital | Royal Tunbridge Wells, Kent | England | United Kingdom | TN2 4QJ |
| 37 | Scunthorpe General Hospital | Scunthorpe | England | United Kingdom | DN15 7BH |
| 38 | Royal Hallamshire Hospital | Sheffield | England | United Kingdom | S1O 2JF |
| 39 | Cancer Research Centre at Weston Park Hospital | Sheffield | England | United Kingdom | S1O 2SJ |
| 40 | Staffordshire General Hospital | Stafford | England | United Kingdom | ST16 3SA |
| 41 | Royal Marsden NHS Foundation Trust - Surrey | Sutton | England | United Kingdom | SM2 5PT |
| 42 | Taunton and Somerset Hospital | Taunton Somerset | England | United Kingdom | TA1 5DA |
| 43 | Torbay Hospital | Torquay Devon | England | United Kingdom | TQ2 7AA |
| 44 | Hillingdon Hospital | Uxbridge | England | United Kingdom | UB8 3NN |
| 45 | Sandwell General Hospital | West Bromwich | England | United Kingdom | B71 4HJ |
| 46 | Good Hope Hospital Trust | West Midlands | England | United Kingdom | B75 7RR |
| 47 | New Cross Hospital | Wolverhampton | England | United Kingdom | WV10 0QP |
| 48 | Worthing Hospital | Worthing | England | United Kingdom | BN11 2DH |
| 49 | Yeovil District Hospital | Yeovil - Somerset | England | United Kingdom | BA21 4AT |
| 50 | Cancer Care Centre at York Hospital | York | England | United Kingdom | Y031 8HE |
| 51 | Centre for Cancer Research and Cell Biology at Belfast City Hospital | Belfast | Northern Ireland | United Kingdom | BT9 7AB |
| 52 | Craigavon Area Hospital | Craigavon | Northern Ireland | United Kingdom | BT63 5QQ |
| 53 | Ulster Hospital | Dundonald | Northern Ireland | United Kingdom | BT16 |
| 54 | Pinderfields Hospital NHS Trust | Wakefield | Scotland | United Kingdom | WF1 4DG |
| 55 | Ysbyty Gwynedd | Bangor | Wales | United Kingdom | LL57 2PW |
| 56 | Velindre Cancer Center at Velindre Hospital | Cardiff | Wales | United Kingdom | CF14 2TL |
| 57 | University Hospital of Wales | Cardiff | Wales | United Kingdom | CF14 4XN |
| 58 | Glan Clywd District General Hospital | Rhyl, Denbighshire | Wales | United Kingdom | LL 18 5UJ |
| 59 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000068182
- BNLI-MCD/FMD
- EU-20035