Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211198
Status:
COMPLETED
Last Update Posted:
2008-03-05
First Post:
2005-09-13
Brief Title:
Study of ONTAK to Treat Cutaneous T-Cell Lymphoma CTCL
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
Open Label Study of ONTAK Denileukin Diftitox DAB389IL-2 to Estimate Response in Cutaneous T-Cell Lymphoma CTCL According to CD25 Status
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 research study is to evaluate how effective ONTAK is in the treatment of cutaneous T-cell Lymphoma CTCL and determine whether the presence of a type of protein called CD25 on the cancer cells makes a difference in how the body responds to the treatment
The hypothesis is that there is no difference in response rate for patients whose tumor cells are CD25 positive or negative
The hypothesis is that there is no difference in response rate for patients whose tumor cells are CD25 positive or negative
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