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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005867
• Other study ID #: BNLI-CHOPVPMITCEBO-GOODRISK
• Secondary ID: CDR0000067900EU-
• Status: Completed
• Phase: Phase 3
• First received: June 2, 2000
• Last updated: June 25, 2013
• Start date: January 1998
• Est. completion date: August 2007

Study information

• Verified date: March 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Biological:
• bleomycin sulfate

Drug:
• CHOP regimen

• cyclophosphamide

• doxorubicin hydrochloride

• etoposide

• mitoxantrone hydrochloride

• prednisolone

• vincristine sulfate

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Stoke Mandeville Hospital	Aylesbury-Buckinghamshire	England
United Kingdom	Horton Hospital	Banbury	England
United Kingdom	Ysbyty Gwynedd	Bangor	Wales
United Kingdom	Basildon University Hospital	Basildon	England
United Kingdom	Centre for Cancer Research and Cell Biology at Belfast City Hospital	Belfast	Northern Ireland
United Kingdom	Birmingham Heartlands Hospital	Birmingham	England
United Kingdom	Bradford Hospitals NHS Trust	Bradford	England
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust	Cambridge	England
United Kingdom	University Hospital of Wales	Cardiff	Wales
United Kingdom	Cheltenham General Hospital	Cheltenham	England
United Kingdom	Countess of Chester Hospital NHS Foundation Trust	Chester	England
United Kingdom	Saint Richards Hospital	Chichester	England
United Kingdom	Essex County Hospital	Colchester	England
United Kingdom	Walsgrave Hospital	Coventry	England
United Kingdom	Russells Hall Hospital	Dudley	England
United Kingdom	Chase Farm Hospital	Enfield	England
United Kingdom	Medway Maritime Hospital	Gillingham Kent	England
United Kingdom	Hull Royal Infirmary	Hull	England
United Kingdom	Hinchingbrooke Hospital	Huntingdon	England
United Kingdom	Queen Elizabeth Hospital	King's Lynn	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Aintree University Hospital	Liverpool	England
United Kingdom	Royal Liverpool and Broadgreen Hospitals NHS Trust	Liverpool	England
United Kingdom	Middlesex Hospital	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	St. George's Hospital	London	England
United Kingdom	St. Thomas' Hospital	London	England
United Kingdom	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England
United Kingdom	Norfolk and Norwich University Hospital	Norwich	England
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England
United Kingdom	Oxford Radcliffe Hospital	Oxford	England
United Kingdom	Pontefract General Infirmary	Pontefract West Yorkshire	England
United Kingdom	Glan Clywd District General Hospital	Rhyl, Denbighshire	Wales
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Rhyl, Denbighshire	Wales
United Kingdom	Oldchurch Hospital	Romford	England
United Kingdom	Scunthorpe General Hospital	Scunthorpe	England
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England
United Kingdom	Southampton University Hospital NHS Trust	Southampton	England
United Kingdom	University Hospital of North Staffordshire	Stoke-On-Trent Staffs	England
United Kingdom	East Surrey Hospital	Surrey	England
United Kingdom	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England
United Kingdom	Pinderfields Hospital NHS Trust	Wakefield	Scotland
United Kingdom	Sandwell General Hospital	West Bromwich	England
United Kingdom	Cancer Care Centre at York Hospital	York	England

Sponsors (1)

Lead Sponsor	Collaborator
Lymphoma Trials Office

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival in patients treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP)			No
Secondary	Failure-free survival, disease specific survival, relapse-free survival, death due to toxicity, response rate, and toxicity at 4 years			Yes