Status:
RECRUITING
A Study To Learn About the Safety Medicine (Called Mylotarg) In People With Acute Myeloid Leukemia
Lead Sponsor:
Pfizer
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
19+ years
Brief 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 a...
Detailed 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 ...
Eligibility Criteria
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
Key Trial Info
Start Date :
December 5 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT05189639
Start Date
December 5 2023
End Date
April 30 2027
Last Update
November 19 2025
Active Locations (1)
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1
Seoul national university hospital
Seoul, South Korea