Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00006250|
Recruitment Status : Unknown
Verified March 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: chlorambucil Drug: dexamethasone Drug: fludarabine phosphate Drug: mitoxantrone hydrochloride||Phase 3|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Official Title:||Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma|
|Study Start Date :||May 2000|
- Time to treatment failure
- Progression-free survival rate
- Overall survival rate
- Clinical remission rate
- Molecular remission rate
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006250
Show 59 Study Locations
|Study Chair:||Andy Haynes, MD||Nottingham City Hospital|