Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076349
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2004-01-20
Brief Title:
SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkins Lymphoma NHL
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 Combination With Rituximab in Patients With Relapsed Indolent or Mantle Cell Non-Hodgkins Lymphoma NHL
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 an open label study combining Rituxan and SDX-105 Rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3 Treatment will repeat every 21 days a cycle Treatment can continue for up to 6 cycles about 4 months if tumor status improves and there are no unacceptable side effects Patients will be followed for up to 2 years or until disease progression
RATIONALE
Rituxan has been shown to increase the sensitivity of cells to chemotherapy The combination of SDX-105 and Rituxan has been effective in both the laboratory and in a recent clinical study with Non-Hodgkins lymphoma patients
PURPOSE
This study will evaluate the safety and effectiveness of SDX-105 plus Rituxan in patients with Non-Hodgkins lymphoma who have relapsed after taking Rituxan
This is an open label study combining Rituxan and SDX-105 Rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3 Treatment will repeat every 21 days a cycle Treatment can continue for up to 6 cycles about 4 months if tumor status improves and there are no unacceptable side effects Patients will be followed for up to 2 years or until disease progression
RATIONALE
Rituxan has been shown to increase the sensitivity of cells to chemotherapy The combination of SDX-105 and Rituxan has been effective in both the laboratory and in a recent clinical study with Non-Hodgkins lymphoma patients
PURPOSE
This study will evaluate the safety and effectiveness of SDX-105 plus Rituxan in patients with Non-Hodgkins lymphoma who have relapsed after taking 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