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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005867
First received: June 2, 2000
Last updated: June 25, 2013
Last verified: March 2007
  Purpose

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.


Condition Intervention Phase
Lymphoma
Biological: bleomycin sulfate
Drug: CHOP regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: mitoxantrone hydrochloride
Drug: prednisolone
Drug: vincristine sulfate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Trial Comparing CHOP ot PMitCEBO in Good Risk Patients With Histologically Aggresive Non Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival in patients treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Failure-free survival, disease specific survival, relapse-free survival, death due to toxicity, response rate, and toxicity at 4 years [ Designated as safety issue: Yes ]

Estimated Enrollment: 310
Study Start Date: January 1998
Study Completion Date: August 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005867

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005867     History of Changes
Other Study ID Numbers: BNLI-CHOPVPMITCEBO-GOODRISK, CDR0000067900, EU-99052
Study First Received: June 2, 2000
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bleomycin
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Mitoxantrone
Vincristine
Alkylating Agents
Analgesics
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2014