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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-17

Study Completion Date

2025-05-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Xospata

Patients who receive Xospata® 40 mg tablet in routine clinical practice according to the drug label approved at the time of marketing authorization.

Gilteritinib Exposure

Intervention Type DRUG

Oral

Interventions

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Gilteritinib Exposure

Oral

Intervention Type DRUG

Other Intervention Names

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Xospata

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No