Monitoring Safety and Effectiveness of Poteligeo 20 mg Mogamulizumab in Adults with Mycosis Fungoides or Sezary Syndrome

What this Trial Is About

This research aims to assess the safety and effectiveness of Poteligeo Injection 20 mg mogamulizumab in adult patients with mycosis fungoides or Se9zary syndrome. It is conducted as a post-marketing surveillance study following regulatory requirements in Korea, focusing on patients who have previously received systemic therapy and are treated with mogamulizumab under approved indications. The study also explores effects in special groups such as elderly patients and those with kidney or liver impairment or prior stem cell transplants. Participants receive mogamulizumab according to routine clinical care without experimental randomization or placebo groups, as this is an observational study. The study monitors treatment from the first administration and continues through the treatment period, including assessments up to 90 days after the last dose. Additional analyses consider effectiveness after the eighth administration, particularly changes in the Global Response Score. Throughout the study, patients undergo safety monitoring for any adverse events or symptoms during treatment. Effectiveness is evaluated by comparing baseline and post-treatment response scores at specified time points. The study involves consented adult patients treated in real-world clinical settings and follows them through their treatment course to gather comprehensive safety and effectiveness data, with a planned end date in November 2028.

Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance