RecruitingNCT05189639

A Study To Learn About the Safety Medicine (Called Mylotarg) In People With Acute Myeloid Leukemia

A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Mylotarg®

Sponsor

Pfizer

Enrollment

165 participants

Start Date

Dec 5, 2023

Study Type

OBSERVATIONAL

Conditions

Acute Myeloid Leukemia

Summary

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Mylotarg) for the potential treatment of acute myeloid leukemia (AML). AML is a disease that affects the body's white blood cells. This study is seeking participants in Korea who: * Are 18 years of age or older * Are adults and newly diagnosed with AML * Currently receive Mylotarg for AML treatment in a hospital * Are capable of a personally signed and dated informed consent document indicating that the participant (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Participant's health will be closely monitored for any unwanted reactions during Mylotarg treatment. Disease progression will also be monitored. This will help determine if Mylotarg is safe to use and its effect on AML treatment.

Eligibility

Min Age: 19 Years

Inclusion Criteria2

Adult Patients newly diagnosed as CD33-positive AML who have been treated\* or are being treated\* or determined to be treated with Mylotarg® by the investigator's medical decision under routine clinical practice (\*patients that have been treated or are being treated with Mylotarg® will be eligible for inclusion during the whole case enrollment period, 2 years after approval date)
Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria2

Patients to whom Mylotarg® is contraindicated as per the local labeling (Patients with a history of hypersensitivity including anaphylaxis to the active substance in Mylotarg® or to any of its components or to any of the excipient.)
Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information

Locations(1)

Seoul national university hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT05189639

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