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The purpose of this surveillance is to assess the safety and efficacy of Poteligeo Inj. 20 mg (mogamulizumab) in routine clinical settings.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poteligeo 20mg | Drug | Poteligeo 20mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Special situation, adverse event, symptom, or disease occurring during treatment with Poteligeo) | Number of participants who experience any adverse event or special situation during Poteligeo treatment and up to 90 days after the last dose, as recorded in CRFs based on medical examinations or spontaneous reports. | From first administration of Poteligeo through 90 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to after 8th administration in Global Response Score (GRS) | Change in Global Response Score (GRS) from baseline (before first dose) to after the 8th administration, assessing skin, nodes, blood, and viscera. CR/PR = Effective; SD/PD/Relapse = Ineffective. | Baseline (Day 1, prior to first dose) and Week 24 (after completion of 8th administration) |
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Inclusion Criteria:
Exclusion Criteria
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A person who has Mycosis fungoides and sezary syndrome.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HaeMi Park | Contact | +82-10-3378-3471 | haemi.park.m8@kyowakirin.com |
| Name | Affiliation | Role |
|---|---|---|
| HaeMi Park | Kyowa Kirin Korea Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kosin University Gospel Hospital | Recruiting | Busan | Busan Metropolitan City | 49267 | South Korea |
There is not a plan to make IPD available.
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| ID | Term |
|---|---|
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
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| ID | Term |
|---|---|
| C549035 | mogamulizumab |
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| Chung-Ang University Hospital | Terminated | Seoul | South Korea |
| Ewha Womans University Mokdong Hospital | Recruiting | Seoul | South Korea |
|
| Samsung Medical Center | Recruiting | Seoul | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |