Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-29 @ 12:25 PM
Study NCT ID:
NCT00384150
Status:
TERMINATED
Last Update Posted:
2015-11-26
First Post:
2006-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retreatment Study of Galiximab + Rituximab in Follicular Non-Hodgkin's Lymphoma (NHL)
Sponsor:
Biogen
Organization:
Study Overview
Official Title:
A Phase III, Open-Label, Multicenter, Single-Arm, Retreatment Study of Galiximab in Combination With Rituximab for Subjects With Relapsed, Follicular Non-Hodgkin's Lymphoma Who Previously Responded on Study 114-NH-301
Status:
TERMINATED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase III, multicenter, global, open-label, single-arm, retreatment study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with relapsed or refractory, follicular NHL who demonstrated a response on Study 114-NH-301 with a time-to-progression \>=6 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: