CompletedNot Applicable

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

South Korea33 participantsStarted 2022-06-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with Adverse Drug Reactions (ADRs) related to important identified and/or potential risks

Timeframe: 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

Timeframe: Up to a maximum of 54 months (until 30 days after the last dose)

Trial details

NCT IDNCT04691648

SponsorAstellas Pharma Korea, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-05-04

View on ClinicalTrials.gov More Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with Adverse Drug Reactions (ADRs) related to important identified and/or potential risks

Timeframe: 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

Timeframe: Up to a maximum of 54 months (until 30 days after the last dose)