Poteligeo (mogamulizumab) for adults with mycosis fungoides or Sézary syndrome
Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance
This project will try Poteligeo (mogamulizumab) in adults with mycosis fungoides or Sézary syndrome who have had at least one prior systemic therapy to see how safe and effective it is in routine care in Korea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Kyowa Kirin Co., Ltd. Industry-sponsored |
| Drugs / interventions | mogamulizumab |
| Locations | 6 sites (Busan, Busan Metropolitan City and 5 other locations) |
| Trial ID | NCT07132567 on ClinicalTrials.gov |
What this trial studies
This post-marketing surveillance is an all-case investigation conducted under Korean MFDS re-examination requirements to collect real-world data on mogamulizumab (POTELIGEO® Injection 20 mg). It enrolls adults with mycosis fungoides or Sézary syndrome who have received one or more prior systemic therapies and are treated with mogamulizumab under the approved Korean indication. As an observational program, it focuses primarily on safety outcomes with secondary analyses of effectiveness, and it will perform exploratory subgroup analyses including elderly patients, those with renal or hepatic impairment, and patients with prior hematopoietic stem cell transplantation. Participating sites are university hospitals in Korea where data are collected during routine clinical care.
Who should consider this trial
Good fit: Adults aged 19 or older in Korea with a confirmed diagnosis of mycosis fungoides or Sézary syndrome who have received at least one prior systemic therapy and who are being treated with mogamulizumab per the approved indication and consent to data use.
Not a fit: Patients with known hypersensitivity to the drug, those using it for non-approved indications, or those who already received the drug in a pre-market clinical trial are excluded and will not be covered by this surveillance.
Why it matters
Potential benefit: If successful, this surveillance could confirm real-world safety and effectiveness of mogamulizumab in Korean patients and help clinicians tailor treatment and monitoring.
How similar studies have performed: Previous randomized trials and clinical experience (for example, MAVORIC and subsequent reports) have shown mogamulizumab activity in mycosis fungoides and Sézary syndrome, so this program builds on established evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults 19 years of age or older 2. Individuals who are confirmed to have received administration of the study drug for the purpose of "the treatment for adult patients with fungoidal granuloma or Sezary syndrome who have received one or more systemic therapies," or who are considered to require administration of the study drug in the investigator's opinion 3. Individuals who (or whose legally acceptable representatives) signed the Consent to Use of Personal Information of their own free will for participation in this use-result surveillance Exclusion Criteria 1. Patients with hypersensitivity to any ingredients of this drug 2. Patients who intend to use this drug for non-approved indications 3. Patients who participated in a pre-market clinical trial of the study drug and received administration of the study drug
Where this trial is running
Busan, Busan Metropolitan City and 5 other locations
- Kosin University Gospel Hospital — Busan, Busan Metropolitan City, South Korea (Recruiting)
- Chung-Ang University Hospital — Seoul, South Korea (Terminated)
- Ewha Womans University Mokdong Hospital — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: HaeMi Park
- Email: haemi.park.m8@kyowakirin.com
- Phone: +82-10-3378-3471
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.