LymphomaPhase 3NCT00003578
High Dose Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma
A Phase 3 study testing CHOP regimen, carmustine and cyclophosphamide in people with Lymphoma, run by Lymphoma Trials Office at 72 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- CHOP regimen, carmustine and cyclophosphamide
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 72 sitesin 4 countries
- Study dates
- Jan 1993to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
72 sites in 4 countries.
72 sites in 4 countries
United Kingdom66 sites
Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, HP21 8AL
Ysbyty Gwynedd
Bangor, Wales, LL57 2PW
Royal United Hospital
Bath, England, BA1 3NG
Belfast City Hospital Trust
Belfast, Northern Ireland, BT9 7AB
City Hospital - Birmingham
Birmingham, England, B18 7QH
Birmingham Heartlands and Solihull NHS Trust (Teaching)
Birmingham, England, B9 5SS
Royal Bournemouth Hospital
Bournemouth, BH7 7DW
Southmead Hospital
Bristol, England, BS10 5NB
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
Queen's Hospital, Burton
Burton-on-Trent, England, DE14 3QH
Kent and Canterbury Hospital
Canterbury, England, CT2 7NR
Law Hospital
Carluke UK, ML8 5ER
Cheltenham General Hospital
Cheltenham, England, GL53 7AN
Countess of Chester Hospital
Chester, England, CH2 1UL
Saint Richards Hospital
Chichester, P019 4SE
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
Chase Farm Hospital
Enfield, NG31 8DG
Epsom General Hospital
Epsom Surrey, KT19 7EG
Grantham and District Hospital
Grantham, NG31 8DG
Royal Free Hospital
Hampstead, London, England, NW3 2QG
Northwick Park Hospital
Harrow, England, HA1 3UJ
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, HD3 3EA
King George Hospital
Ilford, Essex, IG3 8YB
Ipswich Hospital NHS Trust
Ipswich, England, IP4 5PD
Queen Elizabeth Hospital
Kings Lynn, PE30 4ET
Leeds Teaching Hospital Trust
Leeds, England, LS1 3EX
University Hospitals of Leicester
Leicester, England, LE1 5WW
Royal Liverpool and Broadgreen Hospitals
Liverpool, England, L7 8XP
Walton General Hospital
Liverpool, L9 1AE
Whipps Cross Hospital
London, England, E11 1NR
Saint Bartholomew's Hospital
London, England, EC1A 7BE
St. Bartholomew's Hospital
London, England, EC1A 7BE
St. Georges Hospital Medical School
London, England, SW17 ORE
University College London Medical School
London, England, W1N 8AA
University College London
London, England, W1W 7EJ
Charing Cross Hospital
London, England, W6 8RF
Middlesex Hospital- Meyerstein Institute
London, England, WIT 3AA
Newham General Hospital
London, E13 8RU
St. Mary's Hospital
London, W2 1NY
Altnagelvin Area Hospital
Londonderry, Northern Ireland, BT47 1SB
Maidstone Hospital
Maidstone, England, ME16 9QQ
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, L63 4JY
Southport and Formby District General Hospital
Merseyside, England, PR8 6NJ
West Middlesex Hospital
Middlesex, N18 1QZ
Milton Keynes General Hospital
Milton Keynes, England, MK6 5LD
Mount Vernon Hospital
Northwood, England, HA6 2RN
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
Derriford Hospital
Plymouth, England, PL6 8DH
East Surrey Hospital
Redhill, RH1 5RH
Oldchurch Hospital
Romford, England, RM7 OBE
Rotherham District General Hospital-NHS Trust
Rotherham, S60 2UD
Pembury Hospital
Royal Tunbridge Wells, Kent, England, TN2 4QJ
Scunthorpe General Hospital
Scunthorpe, DN15 7BH
Sheffield Teaching Hospitals
Sheffield, England, S1O 2JF
Weston Park Hospital
Sheffield, England, S1O 2SJ
Royal South Hants Hospital
Southampton, England, SO14 0YG
Staffordshire General Hospital
Stafford, ST16 3SA
Royal Marsden Hospital
Sutton, England, SM2 5PT
Torbay Hospital
Torquay Devon, England, TQ2 7AA
Hillingdon Hospital
Uxbridge, England, UB8 3NN
Sandwell District General Hospital
West Bromwich, England
Good Hope Hospital Trust
West Midlands, England, B75 7RR
Pontefract General Infirmary
West Yorks, England, WF8 1PL
New Cross Hospital
Wolverhampton, England, WV10 0QP
Norway3 sites
Norwegian Radium Hospital
Oslo, N-0310
Ullevall Hospital
Oslo, N-0407 4
University of Tromso
Tromsø, N-9037
Denmark2 sites
Aarhus Amtssygehus
Aarhus, DK 8000
Rigshospitalet
Copenhagen, 2100
About this study
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
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.
Read the 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.
- Conditions
- Lymphoma
- Being tested
- CHOP regimen, carmustine, cyclophosphamide, cytarabine, doxorubicin hydrochloride
- 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
- Medical subject headings
- Lymphoma, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOP regimenDrug
carmustineDrug
cyclophosphamideDrug
cytarabineDrug
etoposideDrug
melphalanDrug
prednisoneDrug
autologous bone marrow transplantationProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2004 (estimated)
- Study startJan 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lymphoma Trials Office
- Sponsor type
- University, hospital or other
- Investigators
- David C. Linch, Study chair, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003578
- Sponsor's protocol ID
- CDR0000066645
- Other IDs
- BNLI-LY02, EU-98039
- Status last verified
- May 2007
- First submitted
- 1 Nov 1999
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00003578
- Acronym / sponsor ID
- CDR0000066645
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Lymphoma Trials OfficeUniversity, hospital or other
- Study start
- Jan 1993
- First posted
- 27 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHOP regimen | Drug | – |
| carmustine | Drug | – |
| cyclophosphamide | Drug | – |
| cytarabine | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| etoposide | Drug | – |
| melphalan | Drug | – |
| prednisone | Drug | – |
| vincristine sulfate | Drug | – |
| autologous bone marrow transplantation | Procedure or surgery | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C. Linch study chair
University College London Hospitals
72 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CHOP regimen, carmustine and cyclophosphamide in people with Lymphoma, run by Lymphoma Trials Office at 72 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United Kingdom, Norway, Denmark, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.