Back to resultsCombination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
bleomycin sulfate
CHOP regimen
cyclophosphamide
doxorubicin hydrochloride
etoposide
mitoxantrone hydrochloride
prednisolone
vincristine sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring stage I grade 3 follicular lymphoma, stage I adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage III grade 3 follicular lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage IV grade 3 follicular lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, contiguous stage II grade 3 follicular lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II grade 3 follicular lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven previously untreated bulky stage IA or stage IB-IV aggressive non-Hodgkin's lymphoma of 1 of the following types: Working formulation: Follicular large cell Diffuse mixed cell Diffuse large cell Diffuse immunoblastic OR REAL classification: Diffuse large B-cell Peripheral T-cell Measurable or evaluable disease Good prognosis defined as no more than one of the following: Stage III/IV disease LDH greater than upper limit of normal ECOG/WHO 2-4 No lymphoblastic or Burkitt's lymphoma No CNS involvement PATIENT CHARACTERISTICS: Age: 18 to 59 Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: Hemoglobin at least 10 g/dL Neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin, AST, and ALT no greater than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: Ejection fraction at least 50% unless dysfunction attributable to lymphoma Other: Not pregnant or nursing Fertile patients must use effective contraception No other concurrent serious uncontrolled medical conditions No other prior malignancy except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to more than 35% of hematopoietic sites Concurrent consolidation radiotherapy allowed Surgery: Not specified
Sites / Locations
- Stoke Mandeville Hospital
- Horton Hospital
- Basildon University Hospital
- Birmingham Heartlands Hospital
- Bradford Hospitals NHS Trust
- Bristol Haematology and Oncology Centre
- Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
- Cheltenham General Hospital
- Countess of Chester Hospital NHS Foundation Trust
- Saint Richards Hospital
- Essex County Hospital
- Walsgrave Hospital
- Russells Hall Hospital
- Chase Farm Hospital
- Medway Maritime Hospital
- Hull Royal Infirmary
- Hinchingbrooke Hospital
- Queen Elizabeth Hospital
- Leicester Royal Infirmary
- Royal Liverpool and Broadgreen Hospitals NHS Trust
- Aintree University Hospital
- Saint Bartholomew's Hospital
- St. Thomas' Hospital
- St. George's Hospital
- Middlesex Hospital
- Clatterbridge Centre for Oncology NHS Trust
- Norfolk and Norwich University Hospital
- Nottingham City Hospital NHS Trust
- Oxford Radcliffe Hospital
- Pontefract General Infirmary
- Oldchurch Hospital
- Scunthorpe General Hospital
- Cancer Research Centre at Weston Park Hospital
- Southampton University Hospital NHS Trust
- University Hospital of North Staffordshire
- East Surrey Hospital
- Royal Marsden NHS Foundation Trust - Surrey
- Sandwell General Hospital
- Cancer Care Centre at York Hospital
- Centre for Cancer Research and Cell Biology at Belfast City Hospital
- Aberdeen Royal Infirmary
- Pinderfields Hospital NHS Trust
- Ysbyty Gwynedd
- University Hospital of Wales
- Glan Clywd District General Hospital
- Mount Vernon Cancer Centre at Mount Vernon Hospital
Outcomes
Primary Outcome Measures
Overall survival in patients treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP)
Secondary Outcome Measures
Failure-free survival, disease specific survival, relapse-free survival, death due to toxicity, response rate, and toxicity at 4 years
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00005867
Brief Title
Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
Official Title
Phase III Trial Comparing CHOP ot PMitCEBO in Good Risk Patients With Histologically Aggresive Non Hodgkin's Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
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 regimen of combination chemotherapy is most effective for non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying two regimens of combination chemotherapy and comparing how well they work in treating patients with aggressive non-Hodgkin's lymphoma.
Detailed Description
OBJECTIVES:
Compare the overall survival, failure free survival, disease specific survival, relapse free survival, and response rate in patients with aggressive non-Hodgkin's lymphoma treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP).
Compare the early and late toxicities of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
Arm I: Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1 and vincristine and bleomycin IV on day 8. Treatment continues every 14 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral prednisolone daily on courses 1 and 2 and every other day beginning on course 3 and continuing until the end of treatment.
Arm II: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, then every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 310 patients (155 per arm) will be accrued for this study over 5 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage I grade 3 follicular lymphoma, stage I adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage III grade 3 follicular lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage IV grade 3 follicular lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, contiguous stage II grade 3 follicular lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II grade 3 follicular lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
310 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
bleomycin sulfate
Intervention Type
Drug
Intervention Name(s)
CHOP regimen
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
mitoxantrone hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednisolone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Primary Outcome Measure Information:
Title
Overall survival in patients treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP)
Secondary Outcome Measure Information:
Title
Failure-free survival, disease specific survival, relapse-free survival, death due to toxicity, response rate, and toxicity at 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically proven previously untreated bulky stage IA or stage IB-IV aggressive non-Hodgkin's lymphoma of 1 of the following types:
Working formulation:
Follicular large cell
Diffuse mixed cell
Diffuse large cell
Diffuse immunoblastic OR
REAL classification:
Diffuse large B-cell
Peripheral T-cell
Measurable or evaluable disease
Good prognosis defined as no more than one of the following:
Stage III/IV disease
LDH greater than upper limit of normal
ECOG/WHO 2-4
No lymphoblastic or Burkitt's lymphoma
No CNS involvement
PATIENT CHARACTERISTICS:
Age:
18 to 59
Performance status:
See Disease Characteristics
Life expectancy:
Not specified
Hematopoietic:
Hemoglobin at least 10 g/dL
Neutrophil count at least 2,000/mm3
Platelet count at least 100,000/mm3
Hepatic:
Bilirubin, AST, and ALT no greater than 1.5 times upper limit of normal
Renal:
Creatinine no greater than 1.7 mg/dL
Cardiovascular:
Ejection fraction at least 50% unless dysfunction attributable to lymphoma
Other:
Not pregnant or nursing
Fertile patients must use effective contraception
No other concurrent serious uncontrolled medical conditions
No other prior malignancy except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
No prior chemotherapy
Endocrine therapy:
Not specified
Radiotherapy:
No prior radiotherapy to more than 35% of hematopoietic sites
Concurrent consolidation radiotherapy allowed
Surgery:
Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Pettengell, MD
Organizational Affiliation
St. George's 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
Horton Hospital
City
Banbury
State/Province
England
ZIP/Postal Code
OX16 9AL
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
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Cheltenham General Hospital
City
Cheltenham
State/Province
England
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Countess of Chester Hospital NHS Foundation Trust
City
Chester
State/Province
England
ZIP/Postal Code
CH2 1UL
Country
United Kingdom
Facility Name
Saint Richards Hospital
City
Chichester
State/Province
England
ZIP/Postal Code
P019 4SE
Country
United Kingdom
Facility Name
Essex County Hospital
City
Colchester
State/Province
England
ZIP/Postal Code
C03 3NB
Country
United Kingdom
Facility Name
Walsgrave Hospital
City
Coventry
State/Province
England
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Russells Hall Hospital
City
Dudley
State/Province
England
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Chase Farm Hospital
City
Enfield
State/Province
England
ZIP/Postal Code
EN 28 JL
Country
United Kingdom
Facility Name
Medway Maritime Hospital
City
Gillingham Kent
State/Province
England
ZIP/Postal Code
ME7 5NY
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
State/Province
England
ZIP/Postal Code
HU3 2KZ
Country
United Kingdom
Facility Name
Hinchingbrooke Hospital
City
Huntingdon
State/Province
England
ZIP/Postal Code
PE18 6NT
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
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Liverpool and Broadgreen Hospitals NHS Trust
City
Liverpool
State/Province
England
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Aintree University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
St. Thomas' Hospital
City
London
State/Province
England
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
State/Province
England
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Middlesex Hospital
City
London
State/Province
England
ZIP/Postal Code
WC1E 6HX
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Trust
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
State/Province
England
ZIP/Postal Code
NR4 7UY
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
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
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
Scunthorpe General Hospital
City
Scunthorpe
State/Province
England
ZIP/Postal Code
DN15 7BH
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
Southampton University Hospital NHS Trust
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
University Hospital of North Staffordshire
City
Stoke-On-Trent Staffs
State/Province
England
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
East Surrey Hospital
City
Surrey
State/Province
England
ZIP/Postal Code
RH1 5RH
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
Sandwell General Hospital
City
West Bromwich
State/Province
England
ZIP/Postal Code
B71 4HJ
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
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
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
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
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Rhyl, Denbighshire
State/Province
Wales
ZIP/Postal Code
LL 18 5UJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
We'll reach out to this number within 24 hrs