Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma

Phase 3

• Conditions: Lymphoma

• Registration Number: NCT00006250
• 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 combination chemotherapy regimen is more effective for non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

* Compare the overall survival rate, progression free survival rate, clinical and molecular remission rates, and time to treatment failure in patients with newly diagnosed stage III or IV follicular non-Hodgkin's lymphoma treated with chlorambucil, mitoxantrone, and dexamethasone versus fludarabine, mitoxantrone, and dexamethasone.

* Compare the efficacy and tolerability of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to International Prognostic Index score \[low risk (score 1) vs intermediate low risk (score 2) vs intermediate high risk (score 3) vs high risk (score 4 or 5)\]. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive mitoxantrone IV on day 1, oral chlorambucil on days 1-10, and oral dexamethasone on days 1-5.

* Arm II: Patients receive mitoxantrone and dexamethasone as in arm I and fludarabine IV on days 1-3.

Treatment continues every 4 weeks for 4-8 courses.

Patients are followed at 3, 6, and 12 months, every 6 months for 1 year, and then annually thereafter until clinical relapse.

PROJECTED ACCRUAL: A total of 500 patients (250 per arm) will be accrued for this study within 4 years.

Study Timeline

• Study Start: 2000-05
• Study First Submitted: 2000-09-11
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2007-03
• Last Update Submitted: 2013-09-19
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to treatment failure
Progression-free survival rate
Overall survival rate

Secondary Outcome Measures

Name	Time	Method
Clinical remission rate
Molecular remission rate

Trial Locations

Locations (59)

Stoke Mandeville Hospital; 🇬🇧 Aylesbury-Buckinghamshire, 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

Kent and Canterbury Hospital; 🇬🇧 Canterbury, England, United Kingdom

St Helier Hospital; 🇬🇧 Carshalton, England, United Kingdom

Saint Richards Hospital; 🇬🇧 Chichester, England, United Kingdom

Walsgrave Hospital; 🇬🇧 Coventry, England, United Kingdom

Dartford & Gravesham NHS Trust, Joyce Green Hospital; 🇬🇧 Dartford Kent, England, United Kingdom

Derbyshire Royal Infirmary; 🇬🇧 Derby, England, United Kingdom

Scroll for more (49 remaining)