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

NCT04691648 | Completed

• 1 other identifier: 2215-PV-001
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

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

Keywords

Gilteritinib; Xospata; Relapsed or refractory Acute Myeloid Leukemia (AML)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

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

• Number of participants with AEs

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

Study Arms (1)

Xospata

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

Drug: Gilteritinib Exposure

Interventions

Gilteritinib Exposure DRUG

Oral

Also known as: Xospata

Xospata

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving Xospata® 40 mg tablet according to the drug label for 54 months from the start date of marketing in Korea.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Korea, Inc.: lead

Study Sites (10)

Site KR82013

Wŏnju, Gangwon-do, 26426, South Korea

Location

Site KR82006

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Site KR82003

Jeollanam-do, Hwasun-gun, 58128, South Korea

Location

Site KR82011

Busan, 47392, South Korea

Location

Site KR82010

Daegu, 41944, South Korea

Location

Site KR82001

Incheon, 21565, South Korea

Location

Site KR82004

Seoul, 03080, South Korea

Location

Site KR82005

Seoul, 03722, South Korea

Location

Site KR82009

Seoul, 05505, South Korea

Location

Site KR82007

Seoul, 07985, South Korea

Location

MeSH Terms

Conditions

Recurrence; Leukemia, Myeloid, Acute

Interventions

gilteritinib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Astellas Pharma Korea, Inc.

  Astellas Pharma Korea, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: December 31, 2020
• Study Start: June 17, 2022
• Primary Completion: May 4, 2025
• Study Completion: May 4, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (10)