Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139841
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2005-08-18
Brief Title:
Safety and Efficacy of Treanda Bendamustine HCl in Patients With Indolent Non-Hodgkins Lymphoma NHL Who Are Refractory to Rituximab
Sponsor:
Cephalon
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Multi-Center Phase III Study to Investigate the Safety and Efficacy of Treanda Bendamustine HCl in Patients With Indolent Non-Hodgkins Lymphoma NHL Who Are Refractory to Rituximab
Status:
COMPLETED
Status Verified Date:
2014-05
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:
SUMMARY This is a multi-center open label study to evaluate the safety and effectiveness of Treanda also known as bendamustine HCl or SDX-105 in patients who have indolent Non-Hodgkins lymphoma and have relapsed within a defined timeframe after taking rituximab Rituxan Treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every 21-day treatment cycle Patients will be treated for 6 cycles unless they develop progressive disease or unacceptable toxicity Those who continue to receive clinical benefit at end of 6 cycles may receive an additional 2 cycles Following the end of treatment patients will be followed for up to 2 years until disease progression or start of another anti-cancer therapy
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