Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337987
Status:
COMPLETED
Last Update Posted:
2015-02-27
First Post:
2006-06-15
Brief Title:
A Pilot Study to Determine the Safety of the Combination of Ontak in Combination With CHOP in Peripheral T-Cell Lymphoma
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
A Pilot Phase II Study to Determine the Safety of the Combination of ONTAK DAB389IL-2 an Interleukin-2 Fusion Toxin in Combination With CHOP in Peripheral T-Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2015-02
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 standard treatment for PTCL is CHOP cyclophosphamide C adriamycin H vincristine O and prednisone P chemotherapy This study is attempting to determine whether adding other treatments to CHOP therapy will improve the chance of the disease going into remission or staying in remission Because other drugs for T-cell lymphoma have not yet been given with CHOP this study is looking at combining CHOP with ONTAK ONTAK has been FDA approved for treatment of Cutaneous T cell Lymphoma and works by specifically binding to a protein on the surface of the tumor cells and killing the cell without causing damage to other types of cells in the body Studies have shown that ONTAK has helped patients with PTCL who have failed chemotherapy
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