Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354926
Status:
COMPLETED
Last Update Posted:
2016-01-07
First Post:
2006-07-18
Brief Title:
Safety and Efficacy Study of an Anti-CD20 Monoclonal Antibody AME-133v to Treat Non-Hodgkins Lymphoma
Sponsor:
Applied Molecular Evolution
Organization:
Applied Molecular Evolution
Study Overview
Official Title:
Open-Label Multicenter Phase 12 Dose-Escalation Study of AME-133v LY 2469298 Administered Intravenously in Four Weekly Doses in Subjects With CD20 Follicular Relapsed or Refractory Non-Hodgkins Lymphoma
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:
This study is designed to provide evidence of the safety and a preliminary understanding of the efficacy of AME 133v
Detailed Description:
The protein engineering of AME-133v is hypothesized to result in an anti-CD20 therapy with greater potency and efficacy in all patients but particularly in genetically defined subpopulations that respond poorly to rituximab because they express a low affinity version of the Fc receptor on their immune effector cells A monoclonal antibody that has increased binding for this receptor should be more effective in stimulating effector cell killing and thus improve response to the antibody
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