Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069758
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2003-09-30
Brief Title:
Safety and Activity of SDX-105 Bendamustine in Patients With Rituximab Refractory Non-Hodgkins Lymphoma
Sponsor:
Cephalon
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Multi-Center Phase II Study to Investigate the Safety and Activity of SDX-105 Bendamustine 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:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Summary As this is an open label study all patients will receive SDX-105 by 30-60 minute intravenous infusion on day 1 and day 2 Treatment will repeat every 21 days Treatment can continue for up to one year in the absence of disease progression or unacceptable toxicity Patients will be followed until disease progression
Rationale Drugs used in chemotherapy such as SDX-105 use different ways to stop tumor cells from dividing so they stop growing or die
Purpose This study will evaluate the effectiveness and safety in non-Hodgkins lymphoma in patients who are refractory to Rituxan
Rationale Drugs used in chemotherapy such as SDX-105 use different ways to stop tumor cells from dividing so they stop growing or die
Purpose This study will evaluate the effectiveness and safety in non-Hodgkins lymphoma in patients who are refractory to Rituxan
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