NCT00050999

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

A Multicenter Phase III Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Two Dose Levels of DAB389IL-2 (9 and 18 Mcg/kg/Day) in Cutaneous T-Cell Lymphoma (CTCL) Patients With Stage Ia-III Disease Who, Following Less Than or Equal to 3 Previous Therapies, Have Recurrent or Persistent Disease That Has Been Biopsy-Documented to Express CD25

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 195 (planned)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.

Conditions

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

Interventions

Type	Name	Description
DRUG	ONTAK

Timeline

• Start date: 1995-06-01
• Primary completion: 2006-09-01
• Completion: 2006-12-01
• First posted: 2003-01-03
• Last updated: 2008-03-05

Locations

35 sites across 10 countries: United States, Australia, Austria, Canada, Germany, Netherlands, Poland, Russia, Switzerland, United Kingdom