Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053092
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2003-01-27
Brief Title:
Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
Sponsor:
Institute of Cancer Research United Kingdom
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
National Mantle Cell Lymphoma Trial - Phase II Randomized Study of FludarabineCyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
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 Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells It is not yet known if combination chemotherapy is more effective with or without rituximab in treating mantle cell lymphoma
PURPOSE Randomized phase II trial to compare the effectiveness of fludarabine and cyclophosphamide combined with rituximab to that of fludarabine and cyclophosphamide alone in treating patients who have mantle cell lymphoma
PURPOSE Randomized phase II trial to compare the effectiveness of fludarabine and cyclophosphamide combined with rituximab to that of fludarabine and cyclophosphamide alone in treating patients who have mantle cell lymphoma
Detailed Description:
OBJECTIVES
Compare the response rates in patients with previously untreated mantle cell lymphoma treated with fludarabine and cyclophosphamide with or without rituximab
Compare the time to disease progression in patients treated with these regimens
Compare the toxicity of these regimens in terms of adverse event profile in these patients
Compare the overall survival of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fludarabine IV and cyclophosphamide IV on days 1-3
Arm II Patients receive rituximab IV on day 1 and fludarabine IV and cyclophosphamide IV on days 2-4
NOTE In both arms fludarabine and cyclophosphamide may be administered orally instead of IV
Treatment repeats every 28 days for 2-8 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 56-82 patients 28-41 per treatment arm will be accrued for this study
Compare the response rates in patients with previously untreated mantle cell lymphoma treated with fludarabine and cyclophosphamide with or without rituximab
Compare the time to disease progression in patients treated with these regimens
Compare the toxicity of these regimens in terms of adverse event profile in these patients
Compare the overall survival of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fludarabine IV and cyclophosphamide IV on days 1-3
Arm II Patients receive rituximab IV on day 1 and fludarabine IV and cyclophosphamide IV on days 2-4
NOTE In both arms fludarabine and cyclophosphamide may be administered orally instead of IV
Treatment repeats every 28 days for 2-8 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 56-82 patients 28-41 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| NCRILG-LY05 | None | None | None |
| NCRI-LY05 | None | None | None |
| ALLG-LY05 | None | None | None |
| EU-20230 | None | None | None |