Learning about the safety of Mylotarg in patients with acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the safety and effects of Mylotarg in adults newly diagnosed with acute myeloid leukemia (AML). Participants will be monitored for adverse reactions and disease progression while receiving Mylotarg as part of their routine treatment. The study is conducted in Korean healthcare centers and involves close health monitoring to gather data on the drug's safety profile and effectiveness in treating AML. The study will help determine any safety concerns associated with Mylotarg in a real-world clinical setting.

Why it matters

Who can join: the full rules

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

Where it's running

• Seoul national university hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.