Back to resultsHigh Dose Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma
Primary Purpose
Lymphoma
Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CHOP regimen
carmustine
cyclophosphamide
cytarabine
doxorubicin hydrochloride
etoposide
melphalan
prednisone
vincristine sulfate
autologous bone marrow transplantation
peripheral blood stem cell transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring 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
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed intermediate or high grade adult non-Hodgkin's lymphoma: Follicular large cell lymphoma Diffuse mixed cell lymphoma Diffuse large cell lymphoma Diffuse immunoblastic lymphoma Poor prognostic features defined as the presence of 2 or 3 of the following: Stage III/IV Lactase dehydrogenase greater than normal ECOG performance status 2-4 A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 16 to 65 Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics Renal: Not specified Other: No other medical condition prohibiting intensive therapy PRIOR CONCURRENT THERAPY: At least 5 years since prior systemic therapy for cancer
Sites / Locations
- Charles University Hospital
- Aarhus Amtssygehus
- Rigshospitalet
- Norwegian Radium Hospital
- Ullevall Hospital
- University of Tromso
- Stoke Mandeville Hospital
- Royal United Hospital
- City Hospital - Birmingham
- Birmingham Heartlands and Solihull NHS Trust (Teaching)
- Southmead Hospital
- Bristol Haematology and Oncology Centre
- Queen's Hospital, Burton
- Kent and Canterbury Hospital
- Cheltenham General Hospital
- Countess of Chester Hospital
- Derbyshire Royal Infirmary
- Royal Free Hospital
- Northwick Park Hospital
- Huddersfield Royal Infirmary
- Ipswich Hospital NHS Trust
- Leeds Teaching Hospital Trust
- University Hospitals of Leicester
- Royal Liverpool and Broadgreen Hospitals
- Whipps Cross Hospital
- Saint Bartholomew's Hospital
- St. Bartholomew's Hospital
- St. Georges Hospital Medical School
- University College London Medical School
- University College London
- Charing Cross Hospital
- Middlesex Hospital- Meyerstein Institute
- Maidstone Hospital
- Christie Hospital N.H.S. Trust
- Clatterbridge Centre for Oncology NHS Trust
- Southport and Formby District General Hospital
- Milton Keynes General Hospital
- Mount Vernon Hospital
- Nottingham City Hospital NHS Trust
- Oxford Radcliffe Hospital
- Derriford Hospital
- Oldchurch Hospital
- Pembury Hospital
- Sheffield Teaching Hospitals
- Weston Park Hospital
- Royal South Hants Hospital
- Royal Marsden Hospital
- Torbay Hospital
- Hillingdon Hospital
- Sandwell District General Hospital
- Good Hope Hospital Trust
- Pontefract General Infirmary
- New Cross Hospital
- Belfast City Hospital Trust
- Altnagelvin Area Hospital
- Ysbyty Gwynedd
- Royal Bournemouth Hospital
- Law Hospital
- Saint Richards Hospital
- Chase Farm Hospital
- Epsom General Hospital
- Grantham and District Hospital
- King George Hospital
- Queen Elizabeth Hospital
- Walton General Hospital
- Newham General Hospital
- St. Mary's Hospital
- West Middlesex Hospital
- East Surrey Hospital
- Rotherham District General Hospital-NHS Trust
- Scunthorpe General Hospital
- Staffordshire General Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00003578
First Posted
November 1, 1999
Last Updated
September 19, 2013
Sponsor
Lymphoma Trials Office
1. Study Identification
Unique Protocol Identification Number
NCT00003578
Brief Title
High Dose Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma
Official Title
A Randomized Trial to Evaluate Early High Dose Therapy and Autologous Bone Marrow Transplantation as Part of Planned Initial Therapy for Poor Risk Intermediate/High Grade NHL
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 1993 (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. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether high dose chemotherapy plus bone marrow transplantation is more effective than high dose chemotherapy alone for intermediate- or high-grade non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy with or without bone marrow transplantation in treating patients who have intermediate- or high-grade non-Hodgkin's lymphoma.
Detailed Description
OBJECTIVES: I. Assess the value of early intensification with autologous bone marrow transplantation or stem cell support in patients with poor prognosis intermediate or high grade non-Hodgkin's lymphoma.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by age (under 50 vs 50 and over), bone marrow involvement (yes vs no), and country. All patients receive cyclophosphamide, doxorubicin, and vincristine on day 1 and prednisone on days 1-5. Courses repeat every 21 days. Patients receive a minimum of 6 courses of treatment in the absence of disease progression and unacceptable toxicity. Arm I: Patients receive carmustine IV over 2 hours on day 1 in week 9 or 10. Etoposide and cytarabine IV are administered over 30 minutes on days 2-5. Melphalan IV is administered over 5 minutes on day 6. Patients receive cryopreserved bone marrow or peripheral blood stem cells on day 7. Arm II: Patients continue conventional therapy. Patients are followed at 8-9 weeks and 6 months.
PROJECTED ACCRUAL: This study will accrue 500 patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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
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)
CHOP regimen
Intervention Type
Drug
Intervention Name(s)
carmustine
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
melphalan
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Procedure
Intervention Name(s)
autologous bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed intermediate or high grade adult non-Hodgkin's lymphoma: Follicular large cell lymphoma Diffuse mixed cell lymphoma Diffuse large cell lymphoma Diffuse immunoblastic lymphoma Poor prognostic features defined as the presence of 2 or 3 of the following: Stage III/IV Lactase dehydrogenase greater than normal ECOG performance status 2-4 A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS: Age: 16 to 65 Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics Renal: Not specified Other: No other medical condition prohibiting intensive therapy
PRIOR CONCURRENT THERAPY: At least 5 years since prior systemic therapy for cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C. Linch
Organizational Affiliation
University College London Hospitals
Official's Role
Study Chair
Facility Information:
Facility Name
Charles University Hospital
City
Prague (Praha)
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Aarhus Amtssygehus
City
Aarhus
ZIP/Postal Code
DK 8000
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway
Facility Name
Ullevall Hospital
City
Oslo
ZIP/Postal Code
N-0407 4
Country
Norway
Facility Name
University of Tromso
City
Tromso
ZIP/Postal Code
N-9037
Country
Norway
Facility Name
Stoke Mandeville Hospital
City
Aylesbury-Buckinghamshire
State/Province
England
ZIP/Postal Code
HP21 8AL
Country
United Kingdom
Facility Name
Royal United Hospital
City
Bath
State/Province
England
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
City Hospital - Birmingham
City
Birmingham
State/Province
England
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Birmingham Heartlands and Solihull NHS Trust (Teaching)
City
Birmingham
State/Province
England
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Southmead Hospital
City
Bristol
State/Province
England
ZIP/Postal Code
BS10 5NB
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
Queen's Hospital, Burton
City
Burton-upon-Trent
State/Province
England
ZIP/Postal Code
DE14 3QH
Country
United Kingdom
Facility Name
Kent and Canterbury Hospital
City
Canterbury
State/Province
England
ZIP/Postal Code
CT2 7NR
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
City
Chester
State/Province
England
ZIP/Postal Code
CH2 1UL
Country
United Kingdom
Facility Name
Derbyshire Royal Infirmary
City
Derby
State/Province
England
ZIP/Postal Code
DE1 2QY
Country
United Kingdom
Facility Name
Royal Free Hospital
City
Hampstead, London
State/Province
England
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Northwick Park Hospital
City
Harrow
State/Province
England
ZIP/Postal Code
HA1 3UJ
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
Ipswich Hospital NHS Trust
City
Ipswich
State/Province
England
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Leeds Teaching Hospital Trust
City
Leeds
State/Province
England
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
University Hospitals of Leicester
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Liverpool and Broadgreen Hospitals
City
Liverpool
State/Province
England
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Whipps Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
E11 1NR
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. Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
St. Georges Hospital Medical School
City
London
State/Province
England
ZIP/Postal Code
SW17 ORE
Country
United Kingdom
Facility Name
University College London Medical School
City
London
State/Province
England
ZIP/Postal Code
W1N 8AA
Country
United Kingdom
Facility Name
University College London
City
London
State/Province
England
ZIP/Postal Code
W1W 7EJ
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Middlesex Hospital- Meyerstein Institute
City
London
State/Province
England
ZIP/Postal Code
WIT 3AA
Country
United Kingdom
Facility Name
Maidstone Hospital
City
Maidstone
State/Province
England
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Christie Hospital N.H.S. Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Trust
City
Merseyside
State/Province
England
ZIP/Postal Code
L63 4JY
Country
United Kingdom
Facility Name
Southport and Formby District General Hospital
City
Merseyside
State/Province
England
ZIP/Postal Code
PR8 6NJ
Country
United Kingdom
Facility Name
Milton Keynes General Hospital
City
Milton Keynes
State/Province
England
ZIP/Postal Code
MK6 5LD
Country
United Kingdom
Facility Name
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
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
State/Province
England
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Oldchurch Hospital
City
Romford
State/Province
England
ZIP/Postal Code
RM7 OBE
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
Sheffield Teaching Hospitals
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2JF
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Royal South Hants Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO14 0YG
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
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 District General Hospital
City
West Bromwich
State/Province
England
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
Pontefract General Infirmary
City
West Yorks
State/Province
England
ZIP/Postal Code
WF8 1PL
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
State/Province
England
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Belfast City Hospital Trust
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Altnagelvin Area Hospital
City
Londonderry
State/Province
Northern Ireland
ZIP/Postal Code
BT47 1SB
Country
United Kingdom
Facility Name
Ysbyty Gwynedd
City
Bangor
State/Province
Wales
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Law Hospital
City
Carluke UK
ZIP/Postal Code
ML8 5ER
Country
United Kingdom
Facility Name
Saint Richards Hospital
City
Chichester
ZIP/Postal Code
P019 4SE
Country
United Kingdom
Facility Name
Chase Farm Hospital
City
Enfield
ZIP/Postal Code
NG31 8DG
Country
United Kingdom
Facility Name
Epsom General Hospital
City
Epsom Surrey
ZIP/Postal Code
KT19 7EG
Country
United Kingdom
Facility Name
Grantham and District Hospital
City
Grantham
ZIP/Postal Code
NG31 8DG
Country
United Kingdom
Facility Name
King George Hospital
City
Ilford, Essex
ZIP/Postal Code
IG3 8YB
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
King's Lynn
ZIP/Postal Code
PE30 4ET
Country
United Kingdom
Facility Name
Walton General Hospital
City
Liverpool
ZIP/Postal Code
L9 1AE
Country
United Kingdom
Facility Name
Newham General Hospital
City
London
ZIP/Postal Code
E13 8RU
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
West Middlesex Hospital
City
Middlesex
ZIP/Postal Code
N18 1QZ
Country
United Kingdom
Facility Name
East Surrey Hospital
City
Redhill
ZIP/Postal Code
RH1 5RH
Country
United Kingdom
Facility Name
Rotherham District General Hospital-NHS Trust
City
Rotherham
ZIP/Postal Code
S60 2UD
Country
United Kingdom
Facility Name
Scunthorpe General Hospital
City
Scunthorpe
ZIP/Postal Code
DN15 7BH
Country
United Kingdom
Facility Name
Staffordshire General Hospital
City
Stafford
ZIP/Postal Code
ST16 3SA
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
High Dose Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma
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