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 range18 Years

SexALL

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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.

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