Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367497
Status:
TERMINATED
Last Update Posted:
2007-11-20
First Post:
2006-08-22
Brief Title:
Safety and Efficacy Study of Salvage Chemotherapy R-ESHAP to Treat Relapsed and Refractory Aggressive Non-Hodgkins Lymphoma
Sponsor:
Keio University
Organization:
Keio University
Study Overview
Official Title:
Phase 2 Study of Rituximab and ESHAP Etoposide Methylprednisolone Cytarabine and Cisplatin in Relapsed and Refractory Aggressive Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The stopping rule was applied because of low response rates
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aggressive non-Hodgkins lymphoma is difficult to handle once it relapses or becomes refractory to chemotherapy Various second or third line chemotherapies which are called salvage chemotherapy were developed without promising results Improvement in efficacy by adding relatively new agent rituximab to chemotherapy is now widely accepted in non-Hodgkins lymphoma This study will test the safety and efficacy of adding rituximab to existing salvage chemotherapy ESHAP R-ESHAP Our aim is also to proceed to high-dose chemotherapy with autologous hematopoietic stem cell transplantation after successful R-ESHAP 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