Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00308087
Status:
TERMINATED
Last Update Posted:
2013-12-27
First Post:
2006-03-28
Brief Title:
Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma a Form of Non-Hodgkins Lymphoma
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Randomized Open Label Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-cell Lymphoma
Status:
TERMINATED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated by sponsor due to low enrollment see details below
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREMIER
Brief Summary:
The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim will be more effective than rituximab alone
Detailed Description:
On 29 May 2009 Bayer began transitioning the sponsorship of this trial to Genzyme As of 29 August 2009 Genzyme assumed responsibility for the close out of the study NOTE This study was originally posted by sponsor Berlex Inc Berlex Inc was renamed to Bayer HealthCare Inc
The study was terminated early due to low enrollment significant changes to the protocol would have been required to keep pace with the changing therapeutic landscape of indolent lymphoma
The study was terminated early due to low enrollment significant changes to the protocol would have been required to keep pace with the changing therapeutic landscape of indolent lymphoma
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 |
|---|---|---|---|
| PREMIER | OTHER | Genzyme | None |
| 91499 | OTHER | None | None |