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Post Marketing Surveillance (PMS) Study of Mylotarg

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05189639
Recruitment Status : Not yet recruiting
First Posted : January 12, 2022
Last Update Posted : April 14, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

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
Acute Myeloid Leukemia

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

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Study Type : Observational
Estimated 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)
Estimated Study Start Date : June 30, 2023
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2027





Primary Outcome Measures :
  1. 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.


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 ]
    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.



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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
newly-diagnosed CD33-positive AML in adults
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05189639    
Other Study ID Numbers: B1761035
First Posted: January 12, 2022    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022
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.