NCT04745234

Mogamulizumab Q4week Dosing in Participants With R/R CTCL

Open-Label, Phase 2 Study to Assess the Safety of Mogamulizumab Given Every 4 Weeks Following Induction in Participants With Relapsed/Refractory Cutaneous T-Cell Lymphoma (CTCL)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Kyowa Kirin, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, Phase 2 study to evaluate the safety and tolerability of mogamulizumab given Q4W following initial weekly induction in adult participants with relapsed/refractory MF and SS subtypes of CTCL. The study is composed of a 28-day Screening Period during which participants are screened for entry into this study, followed by a treatment period of up to 2 years from Cycle 1 Day 1.

Conditions

• Cutaneous T-Cell Lymphoma, Relapsed
• Cutaneous T-Cell Lymphoma Refractory

Interventions

Type	Name	Description
DRUG	Mogamulizumab	For the first 28-day induction cycle (C1), mogamulizumab 1 mg/kg will be administered as an IV infusion through a 0.22- or 0.2-μm in-line filter over at least 60 minutes on Days 1, 8, 15, and 22. For all subsequent 28-day cycles (C2, 3, 4, etc.), mogamulizumab 2 mg/kg will be administered as an IV infusion over at least 60 minutes on Day 1 of each subsequent therapy cycle.

Timeline

• Start date: 2021-08-16
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2021-02-09
• Last updated: 2024-04-25

Locations

16 sites across 5 countries: United States, France, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study