Ignite Creation Date:
2024-05-05 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00715208
Status:
COMPLETED
Last Update Posted:
2013-04-29
First Post:
2008-07-11
Brief Title:
Phase 2 Study of VELCADE Bortezomib in Patients With Relapsed Follicular Lymphoma
Sponsor:
Millennium Pharmaceuticals Inc
Organization:
Millennium Pharmaceuticals Inc
Study Overview
Official Title:
A Two-Arm Non-Randomized Multicenter Phase 2 Study of VELCADE Bortezomib in Combination With Rituximab Cyclophosphamide and Prednisone With or Without Doxorubicin Followed by Rituximab Maintenance in Patients With Relapsed Follicular Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-04
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 is a phase 2 two-arm non-randomized open-label multicenter study evaluating the safety and efficacy of 2 VELCADE-containing regimens Patients will be treated with either a combination of VELCADE rituximab cyclophosphamide doxorubicin and prednisone VELCADE-R-CAP or a combination of VELCADE rituximab cyclophosphamide and prednisone VELCADE-R-CP based on investigator preference Following completion of the treatment period patients will receive maintenance therapy with rituximab up to a maximum of 2 years
Detailed Description:
None
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