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

June 25, 2013 updated by: Lymphoma Trials Office

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

310

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Aylesbury-Buckinghamshire, England, United Kingdom, HP21 8AL
        • Stoke Mandeville Hospital
      • Banbury, England, United Kingdom, OX16 9AL
        • Horton Hospital
      • Basildon, England, United Kingdom, SS16 5NL
        • Basildon University Hospital
      • Birmingham, England, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Bradford, England, United Kingdom, BD9 6RJ
        • Bradford Hospitals NHS Trust
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology centre
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
      • Cheltenham, England, United Kingdom, GL53 7AN
        • Cheltenham General Hospital
      • Chester, England, United Kingdom, CH2 1UL
        • Countess Of Chester Hospital NHS Foundation Trust
      • Chichester, England, United Kingdom, P019 4SE
        • Saint Richards Hospital
      • Colchester, England, United Kingdom, C03 3NB
        • Essex County Hospital
      • Coventry, England, United Kingdom, CV2 2DX
        • Walsgrave Hospital
      • Dudley, England, United Kingdom, DY1 2HQ
        • Russells Hall Hospital
      • Enfield, England, United Kingdom, EN 28 JL
        • Chase Farm Hospital
      • Gillingham Kent, England, United Kingdom, ME7 5NY
        • Medway Maritime Hospital
      • Hull, England, United Kingdom, HU3 2KZ
        • Hull Royal Infirmary
      • Huntingdon, England, United Kingdom, PE18 6NT
        • Hinchingbrooke Hospital
      • King's Lynn, England, United Kingdom, PE30 4ET
        • Queen Elizabeth Hospital
      • Leicester, England, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • Liverpool, England, United Kingdom, L9 7AL
        • Aintree University Hospital
      • Liverpool, England, United Kingdom, L7 8XP
        • Royal Liverpool and Broadgreen Hospitals NHS Trust
      • London, England, United Kingdom, SW17 0QT
        • St. George's Hospital
      • London, England, United Kingdom, EC1A 7BE
        • Saint Bartholomew's Hospital
      • London, England, United Kingdom, SE1 7EH
        • St. Thomas' Hospital
      • London, England, United Kingdom, WC1E 6HX
        • Middlesex Hospital
      • Merseyside, England, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology NHS Trust
      • Norwich, England, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham City Hospital NHS Trust
      • Oxford, England, United Kingdom, 0X3 9DU
        • Oxford Radcliffe Hospital
      • Pontefract West Yorkshire, England, United Kingdom, WF8 1PL
        • Pontefract General Infirmary
      • Romford, England, United Kingdom, RM7 OBE
        • Oldchurch Hospital
      • Scunthorpe, England, United Kingdom, DN15 7BH
        • Scunthorpe General Hospital
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Cancer Research Centre at Weston Park Hospital
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton University Hospital NHS Trust
      • Stoke-On-Trent Staffs, England, United Kingdom, ST4 6QG
        • University Hospital of North Staffordshire
      • Surrey, England, United Kingdom, RH1 5RH
        • East Surrey Hospital
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden NHS Foundation Trust - Surrey
      • West Bromwich, England, United Kingdom, B71 4HJ
        • Sandwell General Hospital
      • York, England, United Kingdom, Y031 8HE
        • Cancer Care Centre at York Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT9 7AB
        • Centre for Cancer Research and Cell Biology at Belfast City Hospital
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Wakefield, Scotland, United Kingdom, WF1 4DG
        • Pinderfields Hospital NHS Trust
    • Wales
      • Bangor, Wales, United Kingdom, LL57 2PW
        • Ysbyty Gwynedd
      • Cardiff, Wales, United Kingdom, CF14 4XN
        • University Hospital of Wales
      • Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
        • Glan Clywd District General Hospital
      • Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
        • Mount Vernon Cancer Centre at Mount Vernon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lymphoma Trials Office

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1998

Study Completion (ACTUAL)

August 1, 2007

Study Registration Dates

First Submitted

June 2, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BNLI-CHOPVPMITCEBO-GOODRISK
  • CDR0000067900 (REGISTRY: PDQ (Physician Data Query))
  • EU-99052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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