Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113802
Status:
TERMINATED
Last Update Posted:
2021-08-19
First Post:
2005-06-10
Brief Title:
Study of Epratuzumab hLL2 in Patients With Waldenstroms Macroglobulinemia
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase II Single-Arm Trial of Epratuzumab an Anti-CD22 Humanized Antibody in Patients With Waldenstroms Macroglobulinemia
Status:
TERMINATED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether epratuzumab provides effective therapy in Waldenströms Macroglobulinemia WM
Detailed Description:
This multi-center single-arm study of epratuzumab is in patients with Waldenströms Macroglobulinemia WM who failed chemotherapy After baseline evaluations patients receive epratuzumab infused over approximately 30-60 minutes at 360 mgm2 administered once weekly for 4 consecutive weeks days 1 8 15 22 Post-treatment evaluations occur on the day of the last infusion then at 6 and 12 weeks Patients without progression of disease continue long-term follow up until disease progression or for at least 5 years with evaluations every 3 months for 2 years then semi-annually Otherwise follow-up is only required until resolution of any treatment related abnormalities
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