Clinical trial NCT05189639: A Study To Learn About the Safety Medicine (Called Mylotarg) In People With Acute Myeloid Leukemia
Official title: A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Mylotarg®
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myeloid Leukemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-01-12
Enrollment: 165
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newly-diagnosed CD33-positive AML in adults

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.

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 Non-Interventional Study (NIS) all treatment and monitoring of the patients will be at the discretion of the investigator as part of routine practice. The study can be performed in Korean health care centers where Mylotarg® is prescribed to treat AML after obtaining informed consent from the patients as whole case enrollment method.

This study is conducted to determine any problems or questions associated in regard to the following clauses under general clinical practice after marketing Mylotarg®, in accordance with the "Re-examination Guideline of New Drugs, Etc.":

1. Serious Adverse Event (SAE)/Adverse Drug Reaction (ADR)
2. Unexpected Adverse Event (AE)/Adverse Drug Reaction (ADR) that has not been reflected in the approved drug label.
3. Known Adverse Drug Reaction (ADR)
4. Non-Serious Adverse Drug Reaction (Non-SADR)
5. Other safety and effectiveness information

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

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
timeFrame: from initiating administration of first dose to the at least 28 calendar days following the last administration of Mylotarg®
Secondary outcomes:
measure: Objective Response Rate - Percentage of Participants With Objective Response
timeFrame: assessed after each cycle (each cycle is 7 days) and all cycles (maximum 3 cycles) are administered
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: