Learning about the safety of Mylotarg in patients with acute myeloid leukemia
A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Mylotarg®
This study is testing how safe Mylotarg is for adults who have just been diagnosed with acute myeloid leukemia while they receive it as part of their regular treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 165 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05189639 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been newly diagnosed with CD33-positive acute myeloid leukemia and are receiving Mylotarg treatment.
Not a fit: Patients who have contraindications to Mylotarg or those who do not consent to the use of their information will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of Mylotarg for treating acute myeloid leukemia.
How similar studies have performed: Similar studies evaluating the safety of treatments for acute myeloid leukemia have shown promising results, but this specific approach with Mylotarg is being assessed in a real-world setting.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.