Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-27 @ 3:11 AM
Study NCT ID:
NCT00006250
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2000-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma
Sponsor:
Lymphoma Trials Office
Organization:
Study Overview
Official Title:
Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: