Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorKyowa Kirin Co., Ltd.
About this trial
The purpose of this surveillance is to assess the safety and efficacy of Poteligeo Inj. 20 mg (mogamulizumab) in routine clinical settings.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
A person who has Mycosis fungoides and sezary syndrome.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Poteligeo 20mg
DrugPoteligeo 20mg
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
From first administration of Poteligeo through 90 days after the last doseSecondary outcomes
1
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.
Time frame
Baseline (Day 1, prior to first dose) and Week 24 (after completion of 8th administration)Sponsors and contacts
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Source ClinicalTrials.gov