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LymphomaPhase 3NCT00005867

Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma

A Phase 3 study testing bleomycin sulfate, CHOP regimen and cyclophosphamide in people with Lymphoma, run by Lymphoma Trials Office at 46 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 59 years
Conditions the study is for
Lymphoma
What is being tested?
bleomycin sulfate, CHOP regimen and cyclophosphamide
How many people
310 participants
Where
46 sitesUnited Kingdom
Study dates
Jan 1998to Aug 2007
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 18 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

United Kingdom46 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Stoke Mandeville Hospital

    Aylesbury-Buckinghamshire, England, HP21 8AL

  • Horton Hospital

    Banbury, England, OX16 9AL

  • Ysbyty Gwynedd

    Bangor, Wales, LL57 2PW

  • Basildon University Hospital

    Basildon, England, SS16 5NL

  • Centre for Cancer Research and Cell Biology at Belfast City Hospital

    Belfast, Northern Ireland, BT9 7AB

  • Birmingham Heartlands Hospital

    Birmingham, England, B9 5SS

  • Bradford Hospitals NHS Trust

    Bradford, England, BD9 6RJ

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

    Cambridge, England, CB2 2QQ

  • University Hospital of Wales

    Cardiff, Wales, CF14 4XN

  • Cheltenham General Hospital

    Cheltenham, England, GL53 7AN

  • Countess of Chester Hospital NHS Foundation Trust

    Chester, England, CH2 1UL

  • Saint Richards Hospital

    Chichester, England, P019 4SE

  • Essex County Hospital

    Colchester, England, C03 3NB

  • Walsgrave Hospital

    Coventry, England, CV2 2DX

  • Russells Hall Hospital

    Dudley, England, DY1 2HQ

  • Chase Farm Hospital

    Enfield, England, EN 28 JL

  • Medway Maritime Hospital

    Gillingham Kent, England, ME7 5NY

  • Hull Royal Infirmary

    Hull, England, HU3 2KZ

  • Hinchingbrooke Hospital

    Huntingdon, England, PE18 6NT

  • Queen Elizabeth Hospital

    Kings Lynn, England, PE30 4ET

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • Royal Liverpool and Broadgreen Hospitals NHS Trust

    Liverpool, England, L7 8XP

  • Aintree University Hospital

    Liverpool, England, L9 7AL

  • Saint Bartholomew's Hospital

    London, England, EC1A 7BE

  • St. Thomas' Hospital

    London, England, SE1 7EH

  • St. George's Hospital

    London, England, SW17 0QT

  • Middlesex Hospital

    London, England, WC1E 6HX

  • Clatterbridge Centre for Oncology NHS Trust

    Merseyside, England, CH63 4JY

  • Norfolk and Norwich University Hospital

    Norwich, England, NR4 7UY

  • Nottingham City Hospital NHS Trust

    Nottingham, England, NG5 1PB

  • Oxford Radcliffe Hospital

    Oxford, England, 0X3 9DU

  • Pontefract General Infirmary

    Pontefract West Yorkshire, England, WF8 1PL

  • Glan Clywd District General Hospital

    Rhyl, Denbighshire, Wales, LL 18 5UJ

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Rhyl, Denbighshire, Wales, LL 18 5UJ

  • Oldchurch Hospital

    Romford, England, RM7 OBE

  • Scunthorpe General Hospital

    Scunthorpe, England, DN15 7BH

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • Southampton University Hospital NHS Trust

    Southampton, England, SO16 6YD

  • University Hospital of North Staffordshire

    Stoke-On-Trent Staffs, England, ST4 6QG

  • East Surrey Hospital

    Surrey, England, RH1 5RH

  • Royal Marsden NHS Foundation Trust - Surrey

    Sutton, England, SM2 5PT

  • Pinderfields Hospital NHS Trust

    Wakefield, Scotland, WF1 4DG

  • Sandwell General Hospital

    West Bromwich, England, B71 4HJ

  • Cancer Care Centre at York Hospital

    York, England, Y031 8HE

Other trials in United Kingdom

About this study

Official title: Phase III Trial Comparing CHOP ot PMitCEBO in Good Risk Patients With Histologically Aggresive Non Hodgkin's Lymphoma

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.

Read the 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.

Conditions
Lymphoma
Being tested
bleomycin sulfate, CHOP regimen, cyclophosphamide, doxorubicin hydrochloride, etoposide
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
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival in patients treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP)

Secondary outcomes (1)

  1. Failure-free survival, disease specific survival, relapse-free survival, death due to toxicity, response rate, and toxicity at 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJan 1998
  3. Study completionAug 2007

Resources

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
310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005867
Sponsor's protocol ID
BNLI-CHOPVPMITCEBO-GOODRISK
Other IDs
CDR0000067900, EU-99052
Status last verified
Mar 2007
First submitted
2 Jun 2000
Last updated
26 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bleomycin sulfate, CHOP regimen and cyclophosphamide in people with Lymphoma, run by Lymphoma Trials Office at 46 sites in United Kingdom.

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: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

What does the primary outcome measure?

Overall survival in patients treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005867.

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 26 Jun 2013; AzTrials last refreshed its copy on 7 Nov 2026.

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