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

Pfizer

Status: Enrolling

Conditions: Acute Myeloid Leukemia

Study type: Observational

Funder types: Industry

Identifiers

NCT05189639

B1761035

NCT05189639 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

This is a prospective, single-arm, open-label, non-interventional, multi-centre, PMS to evaluate safety and effectiveness of Mylotarg® in patients with newly-diagnosed CD33-positive AML. As this is a Non-Interventional Study (NIS) all treatment and monitoring of the patients will be at the discretion of the investigator as part of routine practice. The study can be performed in Korean health care centers where Mylotarg® is prescribed to treat AML after obtaining informed consent from the patients as whole case enrollment method.

This study is conducted to determine any problems or questions associated in regard to the following clauses under general clinical practice after marketing Mylotarg®, in accordance with the "Re-examination Guideline of New Drugs, Etc.":

1. Serious Adverse Event (SAE)/Adverse Drug Reaction (ADR)
2. Unexpected Adverse Event (AE)/Adverse Drug Reaction (ADR) that has not been reflected in the approved drug label.
3. Known Adverse Drug Reaction (ADR)
4. Non-Serious Adverse Drug Reaction (Non-SADR)
5. Other safety and effectiveness information

Enrollment: 165 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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