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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma

Intervention: bleomycin sulfate (Biological); CHOP regimen (Drug); cyclophosphamide (Drug); doxorubicin hydrochloride (Drug); etoposide (Drug); mitoxantrone hydrochloride (Drug); prednisolone (Drug); vincristine sulfate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Lymphoma Trials Office

Official(s) and/or principal investigator(s):
Ruth Pettengell, MD, Study Chair, Affiliation: St. George's Hospital

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. 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.

Clinical Details

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

Study design: Allocation: Randomized, Primary Purpose: Treatment

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

Secondary outcome: Failure-free survival, disease specific survival, relapse-free survival, death due to toxicity, response rate, and toxicity at 4 years

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

Minimum age: 18 Years. Maximum age: 59 Years. Gender(s): Both.

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

Locations and Contacts

Stoke Mandeville Hospital, Aylesbury-Buckinghamshire, England HP21 8AL, United Kingdom

Horton Hospital, Banbury, England OX16 9AL, United Kingdom

Basildon University Hospital, Basildon, England SS16 5NL, United Kingdom

Birmingham Heartlands Hospital, Birmingham, England B9 5SS, United Kingdom

Bradford Hospitals NHS Trust, Bradford, England BD9 6RJ, United Kingdom

Bristol Haematology and Oncology Centre, Bristol, England BS2 8ED, United Kingdom

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust, Cambridge, England CB2 2QQ, United Kingdom

Cheltenham General Hospital, Cheltenham, England GL53 7AN, United Kingdom

Countess of Chester Hospital NHS Foundation Trust, Chester, England CH2 1UL, United Kingdom

Saint Richards Hospital, Chichester, England P019 4SE, United Kingdom

Essex County Hospital, Colchester, England C03 3NB, United Kingdom

Walsgrave Hospital, Coventry, England CV2 2DX, United Kingdom

Russells Hall Hospital, Dudley, England DY1 2HQ, United Kingdom

Chase Farm Hospital, Enfield, England EN 28 JL, United Kingdom

Medway Maritime Hospital, Gillingham Kent, England ME7 5NY, United Kingdom

Hull Royal Infirmary, Hull, England HU3 2KZ, United Kingdom

Hinchingbrooke Hospital, Huntingdon, England PE18 6NT, United Kingdom

Queen Elizabeth Hospital, King's Lynn, England PE30 4ET, United Kingdom

Leicester Royal Infirmary, Leicester, England LE1 5WW, United Kingdom

Aintree University Hospital, Liverpool, England L9 7AL, United Kingdom

Royal Liverpool and Broadgreen Hospitals NHS Trust, Liverpool, England L7 8XP, United Kingdom

Middlesex Hospital, London, England WC1E 6HX, United Kingdom

Saint Bartholomew's Hospital, London, England EC1A 7BE, United Kingdom

St. George's Hospital, London, England SW17 0QT, United Kingdom

St. Thomas' Hospital, London, England SE1 7EH, United Kingdom

Clatterbridge Centre for Oncology NHS Trust, Merseyside, England CH63 4JY, United Kingdom

Norfolk and Norwich University Hospital, Norwich, England NR4 7UY, United Kingdom

Nottingham City Hospital NHS Trust, Nottingham, England NG5 1PB, United Kingdom

Oxford Radcliffe Hospital, Oxford, England 0X3 9DU, United Kingdom

Pontefract General Infirmary, Pontefract West Yorkshire, England WF8 1PL, United Kingdom

Oldchurch Hospital, Romford, England RM7 OBE, United Kingdom

Scunthorpe General Hospital, Scunthorpe, England DN15 7BH, United Kingdom

Cancer Research Centre at Weston Park Hospital, Sheffield, England S1O 2SJ, United Kingdom

Southampton University Hospital NHS Trust, Southampton, England SO16 6YD, United Kingdom

University Hospital of North Staffordshire, Stoke-On-Trent Staffs, England ST4 6QG, United Kingdom

East Surrey Hospital, Surrey, England RH1 5RH, United Kingdom

Royal Marsden NHS Foundation Trust - Surrey, Sutton, England SM2 5PT, United Kingdom

Sandwell General Hospital, West Bromwich, England B71 4HJ, United Kingdom

Cancer Care Centre at York Hospital, York, England Y031 8HE, United Kingdom

Centre for Cancer Research and Cell Biology at Belfast City Hospital, Belfast, Northern Ireland BT9 7AB, United Kingdom

Aberdeen Royal Infirmary, Aberdeen, Scotland AB25 2ZN, United Kingdom

Pinderfields Hospital NHS Trust, Wakefield, Scotland WF1 4DG, United Kingdom

Ysbyty Gwynedd, Bangor, Wales LL57 2PW, United Kingdom

University Hospital of Wales, Cardiff, Wales CF14 4XN, United Kingdom

Glan Clywd District General Hospital, Rhyl, Denbighshire, Wales LL 18 5UJ, United Kingdom

Mount Vernon Cancer Centre at Mount Vernon Hospital, Rhyl, Denbighshire, Wales LL 18 5UJ, United Kingdom

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: January 1998
Last updated: June 25, 2013

Page last updated: August 20, 2015

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