Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004889
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2000-03-07
Brief Title:
Rituximab in Treating Patients With Waldenstroms Macroglobulinemia
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Study of Rituximab Rituxan Mabthera in Waldenstroms Macroglobulinemia
Status:
COMPLETED
Status Verified Date:
2012-07
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 can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase II trial to study the effectiveness of rituximab in treating patients who have Waldenstroms macroglobulinemia
PURPOSE Phase II trial to study the effectiveness of rituximab in treating patients who have Waldenstroms macroglobulinemia
Detailed Description:
OBJECTIVES I Determine the objective response time to treatment failure and toxicity in patients with Waldenstroms macroglobulinemia treated with rituximab II Correlate expression and changes in expression of CD20 on patient plasma cells and B-cells with clinical responses
OUTLINE This is a multicenter study Patients receive rituximab IV weekly for 4 weeks Treatment may be repeated 2 months later in patients with stable disease partial response or complete response Patients are followed every 6 months for 2 years
PROJECTED ACCRUAL A total of 12-25 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive rituximab IV weekly for 4 weeks Treatment may be repeated 2 months later in patients with stable disease partial response or complete response Patients are followed every 6 months for 2 years
PROJECTED ACCRUAL A total of 12-25 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1709 | None | None | None |
| UCLA-9909016 | None | None | None |