A Study to Assess the Safety of Xospata in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-Like Tyrosine Kinase 3 (FLT3) Mutation

May 30, 2025 updated by: Astellas Pharma Korea, Inc.

An Observational Study to Assess the Safety of Xospata® 40 mg Tablet When Administered in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-Like Tyrosine Kinase 3 (FLT3) Mutation

The objective of this study is to describe the observed safety profile of Xospata® 40 mg tablet when administered in patients with relapsed or refractory AML with FLT3 mutation in routine clinical practice in Korea.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is being mandated by Ministry of Food and Drug Safety (MFDS) as a part of the Korea-Risk Management Plan (K-RMP) to assess safety in patients with relapsed or refractory AML with FLT3 mutation in routine clinical practice in Korea. This study collects data for 54 months according to the purpose of this study in routine clinical practice as an observational study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Site KR82011
      • Daegu, Korea, Republic of, 41944
        • Site KR82010
      • Incheon, Korea, Republic of, 21565
        • Site KR82001
      • Seoul, Korea, Republic of, 03080
        • Site KR82004
      • Seoul, Korea, Republic of, 03722
        • Site KR82005
      • Seoul, Korea, Republic of, 05505
        • Site KR82009
      • Seoul, Korea, Republic of, 07985
        • Site KR82007
    • Gangwon-do
      • Wonju-si, Gangwon-do, Korea, Republic of, 26426
        • Site KR82013
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
        • Site KR82006
    • Hwasun-gun
      • Jeollanam-do, Hwasun-gun, Korea, Republic of, 58128
        • Site KR82003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients receiving Xospata® 40 mg tablet according to the drug label for 54 months from the start date of marketing in Korea.

Description

Inclusion Criteria:

  • Patients who receive Xospata® 40 mg tablet according to the drug label approved at the time of marketing authorization in routine clinical practice.
  • Patients who voluntarily signed the written informed consent form.

Exclusion Criteria:

  • Patients who meet the section 'Do not administer to the following patients' in the precautions for use given at the time of marketing authorization.
  • Patients who use the drug for an off-label purpose.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Xospata
Patients who receive Xospata® 40 mg tablet in routine clinical practice according to the drug label approved at the time of marketing authorization.
Drug: Gilteritinib Exposure
Oral
Other Names:
  • Xospata

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with Adverse Drug Reactions (ADRs) related to important identified and/or potential risks
Time Frame: Up to a maximum of 54 months (until 30 days after the last dose)
An Adverse Drug Reaction refers to any unfavorable and unintended reaction occurring with a normal administration or use of the medicinal product that a causal relationship to the medicinal product cannot be ruled out. Number of ADRs related to important identified risks such as posterior reversible encephalopathy syndrome (PRES), QT prolongation, differentiation syndrome, and/or important potential risks such as pancreatitis, embryo-fetal lethality, suppressed fetal growth and teratogenicity, will be recorded.
Up to a maximum of 54 months (until 30 days after the last dose)
Number of participants with serious ADRs related to important identified and/or potential risks
Time Frame: Up to a maximum of 54 months (until 30 days after the last dose)
An ADR refers to any unfavorable and unintended reaction occurring with a normal administration or use of the medicinal product that a causal relationship to the medicinal product cannot be ruled out. Number of ADRs related to important identified risks such as posterior reversible encephalopathy syndrome (PRES), QT prolongation, differentiation syndrome, and/or important potential risks such as pancreatitis, embryo-fetal lethality, suppressed fetal growth and teratogenicity, will be recorded. An ADR is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires inpatient hospitalization or prolongation of hospitalization, or other medically important event.
Up to a maximum of 54 months (until 30 days after the last dose)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with ADRs related to identified risks and considered not important
Time Frame: Up to a maximum of 54 months (until 30 days after the last dose)
An ADR refers to any unfavorable and unintended reaction occurring with a normal administration or use of the medicinal product that a causal relationship to the medicinal product cannot be ruled out. Number of ADRs related to identified risks but considered not important, such as other ADRs described by the Korean package insert, will be recorded. An ADR is considered "serious" if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires inpatient hospitalization or prolongation of hospitalization, or other medically important event.
Up to a maximum of 54 months (until 30 days after the last dose)
Number of participants with AEs
Time Frame: Up to a maximum of 54 months (until 30 days after the last dose)
An AE is defined as any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE is considered "serious" if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires inpatient hospitalization or prolongation of hospitalization, or other medically important event. Causal relationship between the study drug is judged by medically qualified investigator either as certain, probable/likely, possible, unlikely, conditional/unclassified or unassessable/unclassifiable.
Up to a maximum of 54 months (until 30 days after the last dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Korea, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Astellas Pharma Korea, Inc., Astellas Pharma Korea, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 4, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 4, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2215-PV-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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