NCT05189639 A Study To Learn About the Safety Medicine (Called Mylotarg) In People With Acute Myeloid Leukemia
| NCT ID | NCT05189639 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pfizer |
| Condition | Acute Myeloid Leukemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 165 participants |
| Start Date | 2023-12-05 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 165 participants in total. It began in 2023-12-05 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT05189639 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05189639 currently recruiting?
Yes, NCT05189639 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT05189639 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05189639 clinical trial?
NCT05189639 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 165 participants.
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