A Study To Learn About the Safety Medicine (Called Mylotarg) In People With Acute Myeloid Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A PROSPECTIVE, SINGLE-ARM, OPEN-LABEL, NON-INTERVENTIONAL, MULTI-CENTRE, POST MARKETING SURVEILLANCE (PMS) STUDY OF MYLOTARG®
Overview
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
Primary outcome measures
- Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) [Time frame: from initiating administration of first dose to the at least 28 calendar days following the last administration of Mylotarg®]
Secondary outcome measures (1)
- Objective Response Rate - Percentage of Participants With Objective Response [Time frame: assessed after each cycle (each cycle is 7 days) and all cycles (maximum 3 cycles) are administered]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Seoul national university hospital — Seoul
Identifiers
NCT: NCT05189639 · B1761035 · NCT05189639