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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Seoul national university hospital
RECRUITING
Seoul
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2023-12-05
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 165
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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