Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Poteligeo 20mg.
- Who it may be relevant to
- Registry conditions: Mycosis Fungoides, Sezary Syndrome. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this surveillance is to assess the safety and efficacy of Poteligeo Inj. 20 mg (mogamulizumab) in routine clinical settings.
Detailed description
This post-marketing surveillance (PMS) is designed as an all-case investigation in accordance with the Korean Ministry of Food and Drug Safety (MFDS) re-examination requirements. It targets adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy and are treated with mogamulizumab (POTELIGEO® Injection 20 mg) under the approved indication in Korea.
Primary Objective: To assess the safety of mogamulizumab for patients treated under the approved indication in Korea.
Secondary Objective: To assess the effectiveness of mogamulizumab for patients treated under the approved indication in Korea.
Exploratory Objective: To perform additional subgroup and exploratory analyses of effectiveness, including evaluation in special populations such as elderly patients, patients with renal or hepatic impairment, and those with a history of hematopoietic stem cell transplantation, treated under the approved indication in Korea
Interventions
- Drug Poteligeo 20mg
Poteligeo 20mg
Primary outcome measures
- Safety (Special situation, adverse event, symptom, or disease occurring during treatment with Poteligeo) [Time frame: From first administration of Poteligeo through 90 days after the last dose]
Secondary outcome measures (1)
- Change from baseline to after 8th administration in Global Response Score (GRS) [Time frame: Baseline (Day 1, prior to first dose) and Week 24 (after completion of 8th administration)]
Eligibility criteria
Inclusion criteria
- Adults 19 years of age or older
- 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
- 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
- Patients with hypersensitivity to any ingredients of this drug
- Patients who intend to use this drug for non-approved indications
- Patients who participated in a pre-market clinical trial of the study drug and received administration of the study drug
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
South Korea · 6 centers
- Kosin University Gospel Hospital — Busan
- Chung-Ang University Hospital — Seoul
- Ewha Womans University Mokdong Hospital — Seoul
- Samsung Medical Center — Seoul
- Seoul National University Hospital — Seoul
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT07132567 · Poteligeo PMS