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

Phase 3

Completed

• Conditions: Lymphoma

• Registration Number: NCT00005867
• Lead Sponsor: Lymphoma Trials Office

Brief 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.

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 Timeline

• Study Start: 1998-01
• Study First Submitted: 2000-06-02
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2007-03
• Study Completion: 2007-08
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Failure-free survival, disease specific survival, relapse-free survival, death due to toxicity, response rate, and toxicity at 4 years

Trial Locations

Locations (46)

Stoke Mandeville Hospital; 🇬🇧 Aylesbury-Buckinghamshire, England, United Kingdom

Horton Hospital; 🇬🇧 Banbury, England, United Kingdom

Basildon University Hospital; 🇬🇧 Basildon, England, 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

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

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