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Post Marketing Surveillance (PMS) Study of Mylotarg

Sponsor
Pfizer (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05189639
Collaborator
(none)
165
Enrollment
54
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This Non-Interventional Study (NIS) is designated as a Post Marketing Surveillance (PMS) and is a commitment to Ministry of Food and Drug Safety (MFDS), as a part of Risk Management Plan (RMP). The safety and effectiveness information of Mylotarg® will be gathered at minimum 165 subjects administered in the setting of routine practice in Korea during the initial 6 years after the approval.10

Condition or Disease Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    165 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Mylotarg(Registered)
    Anticipated Study Start Date :
    Jun 30, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2027
    Anticipated Study Completion Date :
    Dec 31, 2027

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Secondary Outcome Measures

    1. Objective Response Rate - Percentage of Participants With Objective Response [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT05189639
    Other Study ID Numbers:
    • B1761035
    First Posted:
    Jan 12, 2022
    Last Update Posted:
    Apr 14, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Apr 14, 2022