Post Marketing Surveillance (PMS) Study of Mylotarg
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|ClinicalTrials.gov Identifier: NCT05189639|
Recruitment Status : Not yet recruiting
First Posted : January 12, 2022
Last Update Posted : April 14, 2022
|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.
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|