Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005609
Status:
COMPLETED
Last Update Posted:
2013-08-16
First Post:
2000-05-02
Brief Title:
Rituximab in Treating Patients With Waldenstroms Macroglobulinemia
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Rituximab for Waldenstroms Macroglobulinemia WM A Phase II Pilot Study for Untreated or Previously Treated Patients
Status:
COMPLETED
Status Verified Date:
2009-09
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 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 response rate in previously treated and previously untreated patients with Waldenstroms macroglobulinemia receiving rituximab II Determine the associated toxicities with this treatment specifically the frequency of febrile or hypotensive events in this patient population
OUTLINE Patients are stratified according to prior treatment yes vs no Patients with prior treatment are further stratified according to type of treatment alkylating agents vs purine nucleoside analogues Patients receive rituximab IV over 4 hours on days 1 8 15 and 22 Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 66 patients 33 per stratum will be accrued for this study within 36 months
OUTLINE Patients are stratified according to prior treatment yes vs no Patients with prior treatment are further stratified according to type of treatment alkylating agents vs purine nucleoside analogues Patients receive rituximab IV over 4 hours on days 1 8 15 and 22 Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 66 patients 33 per stratum will be accrued for this study within 36 months
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 |
|---|---|---|---|
| E-3A98 | None | None | None |