Studies safety of Mylotarg in adults with acute myeloid leukemia
Monitors safety and effects of Mylotarg in adults newly diagnosed with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: A Study To Learn About the Safety Medicine (Called Mylotarg) In People With Acute Myeloid Leukemia
Key facts
- Where
- Seoul, South KoreaSee the site
Where in South Korea
- Seoul National University HospitalSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT05189639
- Record updated
- 24 July 2026
- Original description
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:Read full original descriptionShow less
A PROSPECTIVE, SINGLE-ARM, OPEN-LABEL, NON-INTERVENTIONAL, MULTI-CENTRE, POST MARKETING SURVEILLANCE (PMS) STUDY OF MYLOTARG®
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.
Inclusion: 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: 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.