E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma

Phase 1 Completed 13 enrolled Eisai Inc.

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this Phase 1 study is to determine the maximum tolerated dose (MTD) through observation of dose limiting toxicity (DLT), which is in advance defined, in patients with peripheral or cutaneous T-cell lymphoma.

Timeline

Start: 2011-07
Primary completion: 2015-08
Completion: 2016-01

Publications

Ohmachi K, Ando K, Ogura M, Uchida T, Tobinai K, Maruyama D, Namiki M, Nakanishi T. E7777 in Japanese patients with relapsed/refractory peripheral and cutaneous T-cell lymphoma: A phase I study. Cancer Sci. 2018 Mar;109(3):794-802. doi: 10.1111/cas.13513. Epub 2018 Feb 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	denileukin diftitox	Protein / enzyme biologic	6 ug/kg	Intravenous
Subject	denileukin diftitox	Protein / enzyme biologic	9 ug/kg	Intravenous
Subject	denileukin diftitox	Protein / enzyme biologic	12 ug/kg	Intravenous
Subject	denileukin diftitox	Protein / enzyme biologic	15 ug/kg	Intravenous
Subject	denileukin diftitox	Protein / enzyme biologic	18 ug/kg	Intravenous

E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma

Summary

Timeline

Publications

Drugs

Indications