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Clinical Trial Summary

The purpose of this trial is to assess the efficacy of E7777 in participants with recurrent or persistent Cutaneous T-Cell Lymphoma (CTCL) in Stage I - III participants as assessed by objective response rate (ORR). A lead-in dose-finding part was used to determine dose level 9 microgram per kilogram (mcg/kg) E7777 that is being used to test efficacy and safety.


Clinical Trial Description

This is a multicenter, open-label study of E7777 in participants with recurrent or persistent CTCL. The study consists of an initial Lead-in part (to select recommended dose of E7777 for Main part), followed by the Main part (to test efficacy). Participants will move through three phases while on study: Pretreatment Phase, Treatment Phase, and Extension Phase and a Follow-up Period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01871727
Study type Interventional
Source Eisai Inc.
Contact
Status Completed
Phase Phase 3
Start date May 30, 2013
Completion date December 14, 2021