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Clinical Trials in South Korea / NCT05189639
Recruiting Observational

A Study To Learn About the Safety Medicine (Called Mylotarg) In People With Acute Myeloid Leukemia

NCT05189639 · tracked via the Priya Life Science South Korea tracker
Sponsor
Pfizer
Phase
Observational
Started
2023-12-05
Last updated
2026-07-24

Condition(s) studied

Acute Myeloid Leukemia

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) — from initiating administration of first dose to the at least 28 calendar days following the last administration of Mylotarg®
    An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of infusion up to 2 years, that were absent before treatment or that worsened relative to pretreatment state. Serious infections including sepsis (excluding opportunistic infections and tuberculosis) were the pre-defined TEAE of special Interest for this study. AEs included both serious and non-serious adverse events.

Trial sites (1)

FacilityCityRegionStatus
Seoul national university hospital Seoul South Korea Recruiting

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Other trials for the same condition

A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Recruiting
A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia Recruiting
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Active, not recruiting
A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) Recruiting
CINC424A2X01B Rollover Protocol Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05189639 on ClinicalTrials.gov ↗ ← All trials in South Korea