Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006250
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2000-09-11
Brief Title:
Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkins Lymphoma
Sponsor:
Lymphoma Trials Office
Organization:
National Cancer Institute NCI
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-Hodgkins 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-Hodgkins 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-Hodgkins 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-Hodgkins 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-Hodgkins 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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20035 | None | None | None |
| BNLI-MCDFMD | None | None | None |