Poteligeo (mogamulizumab) for adults with mycosis fungoides or Sézary syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Kosin University Gospel Hospital
  Busan, Busan Metropolitan City, South Korea Recruiting
• 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
• Chung-Ang University Hospital
  Seoul, South Korea Terminated

Study contacts

• Study coordinator: Hyejin Noh
• Email: hyejin.noh.2u@kyowakirin.com
• Phone: +82-10-3378-3471

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Identifying biomarkers in patients with skin lymphomas.

  This study is trying to find specific markers in the blood and skin of people with skin lymphomas to see if they can help improve treatment options for patients with Mycosis Fungoides and Sézary Syndrome.

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• Mogamulizumab-associated rash in people with mycosis fungoides or Sézary syndrome

  See if a rash that appears while taking mogamulizumab is a drug-related rash and how it links to treatment response in adults with relapsed or refractory mycosis fungoides or Sézary syndrome.

  Recruiting at 2 sites City of Hope Medical Center · Duarte, California and 9 other locations · NCT07003100

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.