Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) MutationNCT04691648
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
An observational study of Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation, run by Astellas Pharma Korea, Inc. at 10 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
- What is being tested?
- Gilteritinib Exposure
- Type of treatment
- Pill or oral medicine
- How many people
- 33 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 17 Jun 2022to 4 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving Xospata® 40 mg tablet according to the drug label for 54 months from the start date of marketing in Korea.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Site KR82011
Busan, 47392
Site KR82010
Daegu, 41944
Site KR82006
Goyang-si, Gyeonggi-do, 10408
Site KR82001
Incheon, 21565
Site KR82003
Jeollanam-do, Hwasun-gun, 58128
Site KR82004
Seoul, 03080
Site KR82005
Seoul, 03722
Site KR82009
Seoul, 05505
Site KR82007
Seoul, 07985
Site KR82013
Wŏnju, Gangwon-do, 26426
About this study
Official title: 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.
Read the 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.
- Being tested
- Gilteritinib Exposure
- Keywords
- Gilteritinib, Xospata, Relapsed or refractory Acute Myeloid Leukemia (AML)
- Medical subject headings
- Recurrence, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gilteritinib ExposureDrug
Also called Xospata
Oral
| Study group | Role | What they receive |
|---|---|---|
| Xospata | Patients who receive Xospata® 40 mg tablet in routine clinical practice according to the drug label approved at the time of marketing authorization. Receives: Drug: Gilteritinib Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Drug Reactions (ADRs) related to important identified and/or potential risks
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.
Measured: 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
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.
Measured: Up to a maximum of 54 months (until 30 days after the last dose)
Secondary outcomes (2)
Number of participants with ADRs related to identified risks and considered not important
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.
Measured: Up to a maximum of 54 months (until 30 days after the last dose)
Number of participants with AEs
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.
Measured: Up to a maximum of 54 months (until 30 days after the last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start17 Jun 2022
- Primary completion4 May 2025
- Study completion4 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Korea, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Astellas Pharma Korea, Inc., Study director, Astellas Pharma Korea, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691648
- Sponsor's protocol ID
- 2215-PV-001
- Status last verified
- May 2025
- First submitted
- 30 Dec 2020
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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/.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04691648
- Acronym / sponsor ID
- 2215-PV-001
- Keywords
- Gilteritinib, Xospata, Relapsed or refractory Acute Myeloid Leukemia (AML)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Astellas Pharma Korea, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 4 May 2025 (actual)
- Study completion
- 4 May 2025 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xospata | – | Drug: Gilteritinib ExposurePatients who receive Xospata® 40 mg tablet in routine clinical practice according to the drug label approved at the time of marketing authorization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving Xospata® 40 mg tablet according to the drug label for 54 months from the start date of marketing in Korea.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gilteritinib ExposureAlso: XospataOral | Drug | Xospata |
Primary outcome
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.
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.
2 secondary outcomes
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)
Number of participants with AEs
Time frame: Up to a maximum of 54 months (until 30 days after the last dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astellas Pharma Korea, Inc. study director
Astellas Pharma Korea, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation, run by Astellas Pharma Korea, Inc. at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.