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2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-26 @ 7:07 PM
Study NCT ID:
NCT00053092
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2003-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
Sponsor:
Institute of Cancer Research, United Kingdom
Organization:
Study Overview
Official Title:
National Mantle Cell Lymphoma Trial - Phase II Randomized Study of Fludarabine/Cyclophosphamide 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?: