Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051012
Status:
COMPLETED
Last Update Posted:
2008-03-05
First Post:
2002-12-31
Brief Title:
Study of ONTAK Denileukin Diftitox in Previously Treated Cutaneous T-Cell Lymphoma Patients
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Multicenter Open-Label Study to Evaluate the Safety and Efficacy of DAB389IL-2 in Cutaneous T-Cell Lymphoma CTCL Patients Following Protocol 93-04-10 Protocol 93-04-11 or Protocol 92-04-01 or Who Meet the Requirements for Protocol 93-04-11 Except Have Biopsy-Documented CTCL That Does Not Express CD25
Status:
COMPLETED
Status Verified Date:
2008-02
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 provide an opportunity for patients who exhibit progressive disease while receiving placebo on the companion 93-04-11 study to receive ONTAK It is also designed to determine the effectiveness of ONTAK in Cutaneous T-cell Lymphoma CTCL patients whose tumors do not express CD25
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