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

Astellas

Status

Completed

Conditions

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

Treatments

Drug: Gilteritinib Exposure

Study type

Observational

Funder types

Industry

Identifiers

NCT04691648

2215-PV-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.