NCT01871727

A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma

A Clinical Study to Demonstrate Safety and Efficacy of E7777 in Persistent or Recurrent Cutaneous T-Cell Lymphoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Persistent or Recurrent Cutaneous T-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	E7777 9 mcg/kg	administered by intravenous (i.v.) infusion over 60 minutes (+/-10 minutes) on 5 consecutive days during every cycle of 21 days

Timeline

• Start date: 2013-05-30
• Primary completion: 2021-12-06
• Completion: 2021-12-14
• First posted: 2013-06-07
• Last updated: 2024-11-13
• Results posted: 2024-11-13

Locations

22 sites across 3 countries: United States, Australia, Puerto Rico