Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00311129
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2006-03-31
Brief Title:
Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Study to Assess the Antitumor Effect and Safety of Fludarabine Phosphate Tablet SH T 586 in Combination With Rituximab Administered in 6 Treatment Cycles 1 Treatment Cycle Rituximab 375 mgm2 iv on Day 1 Along With 5-Consecutive Day Oral Dosing of SH T 586 40 mgm2Day From Day 1 to Day 5 Followed by an Observation Period of 23 Days in Patients With Indolent Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-12
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:
The purpose of this study is to assess the antitumor effect and safety of fludarabine phosphate tablet in combination with rituximab in patient with indolent lymphoma
Detailed Description:
As of 29 May 2009 the clinical trial sponsor is Genzyme Corporation NOTE This study was originally posted by sponsor Schering AG Germany which was subsequently renamed to Bayer Schering Pharma AG Germany
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 |
|---|---|---|---|
| 91456 | None | None | None |