NCT00211198

Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL)

Open Label Study of ONTAK® (Denileukin Diftitox, DAB389IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma, T-Cell, Cutaneous

Interventions

Type	Name	Description
DRUG	ONTAK (denileukin difitox, DAB389IL-2)

Timeline

• Start date: 2001-05-01
• Primary completion: 2005-01-01
• Completion: 2006-01-01
• First posted: 2005-09-21
• Last updated: 2008-03-05

Locations

9 sites across 1 country: United States