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

Phase 4 Completed 86 enrolled Eisai Inc.

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 1995-09
Primary completion: 2006-10
Completion: 2006-12

Publications

Duvic M, Geskin L, Prince HM. Duration of response in cutaneous T-cell lymphoma patients treated with denileukin diftitox: results from 3 phase III studies. Clin Lymphoma Myeloma Leuk. 2013 Aug;13(4):377-84. doi: 10.1016/j.clml.2013.02.020. Epub 2013 Jun 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	denileukin diftitox	Protein / enzyme biologic	9 ug/kg	Intravenous
Subject	denileukin diftitox	Protein / enzyme biologic	18 ug/kg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications