A Study To Learn About the Safety Medicine (Called Mylotarg) In People With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT05189639|
Recruitment Status : Not yet recruiting
First Posted : January 12, 2022
Last Update Posted : March 17, 2023
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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.
|Condition or disease|
|Acute Myeloid Leukemia|
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.":
- Serious Adverse Event (SAE)/Adverse Drug Reaction (ADR)
- Unexpected Adverse Event (AE)/Adverse Drug Reaction (ADR) that has not been reflected in the approved drug label.
- Known Adverse Drug Reaction (ADR)
- Non-Serious Adverse Drug Reaction (Non-SADR)
- Other safety and effectiveness information
|Study Type :||Observational|
|Estimated Enrollment :||165 participants|
|Official Title:||A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Mylotarg(Registered)|
|Estimated Study Start Date :||June 30, 2023|
|Estimated Primary Completion Date :||December 31, 2027|
|Estimated Study Completion Date :||December 31, 2027|
- 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® ]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.
- 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 ]Percentage of participants with OR based assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed remission are those with repeat bone marrow showing less than 5 percent (%) myeloblasts with normal maturation of all cell lines and absolute values of the peripheral blood lasting at least 2 months. PR are those with all CR criteria except at least 50% decrease in the blasts over the pretreatment.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||19 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Adult Patients newly diagnosed as CD33-positive AML
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05189639
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|
|Other Study ID Numbers:||
|First Posted:||January 12, 2022 Key Record Dates|
|Last Update Posted:||March 17, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.|
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type