NCT00051012

Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 86 (planned)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma, T-Cell, Cutaneous
• Mycosis Fungoides
• Sezary Syndrome

Interventions

Type	Name	Description
DRUG	ONTAK

Timeline

• Start date: 1995-09-01
• Primary completion: 2006-10-01
• Completion: 2006-12-01
• First posted: 2003-01-03
• Last updated: 2008-03-05

Locations

34 sites across 9 countries: United States, Australia, Austria, Canada, Germany, Poland, Russia, Switzerland, United Kingdom