Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020800
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2001-07-11
Brief Title:
Rituximab Plus Fludarabine in Treating Patients With Waldenstroms Macroglobulinemia
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Study of Combination Rituxan Rituximab Mabthera and Fludarabine Therapy in Lymphoplasmacytic Lymphoma Waldenstroms Macroglobulinemia
Status:
COMPLETED
Status Verified Date:
2013-01
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 Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Drugs used in chemotherapy use different way to stop cancer cells from dividing so they stop growing or die Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of rituximab plus fludarabine in treating patients who have Waldenstroms macroglobulinemia
PURPOSE Phase II trial to study the effectiveness of rituximab plus fludarabine in treating patients who have Waldenstroms macroglobulinemia
Detailed Description:
OBJECTIVES
Determine the objective response and time to treatment failure in patients with Waldenstroms macroglobulinemia treated with rituximab and fludarabine
Determine the toxicity of this regimen in these patients
Determine if molecular remissions are achievable in patients attaining a clinical complete response when treated with this regimen
OUTLINE This is a multicenter study
Patients receive rituximab IV over 3-6 hours once weekly on weeks 1-4 17 18 30 and 31 and fludarabine IV over 10-30 minutes once daily for 5 days on weeks 5 9 13 19 23 and 27
Patients are followed at least every 2 months for 2 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Determine the objective response and time to treatment failure in patients with Waldenstroms macroglobulinemia treated with rituximab and fludarabine
Determine the toxicity of this regimen in these patients
Determine if molecular remissions are achievable in patients attaining a clinical complete response when treated with this regimen
OUTLINE This is a multicenter study
Patients receive rituximab IV over 3-6 hours once weekly on weeks 1-4 17 18 30 and 31 and fludarabine IV over 10-30 minutes once daily for 5 days on weeks 5 9 13 19 23 and 27
Patients are followed at least every 2 months for 2 years
PROJECTED ACCRUAL A total of 40 patients 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 |
|---|---|---|---|
| NCI-G01-1960 | None | None | None |
| UCLA-0101063 | None | None | None |