Clinical trial NCT04691648: 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
Official title: An Observational Study to Assess the Safety of Xospata® 40 mg Tablet When Administered in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-Like Tyrosine Kinase 3 (FLT3) Mutation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
Keywords: Gilteritinib
Xospata
Relapsed or refractory Acute Myeloid Leukemia (AML)
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2020-12-31
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
measure: 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)
Secondary outcomes:
measure: Number of participants with ADRs related to identified risks and considered not important
timeFrame: Up to a maximum of 54 months (until 30 days after the last dose)
measure: Number of participants with AEs
timeFrame: Up to a maximum of 54 months (until 30 days after the last dose)
Other outcomes:
Locations:
city: Wonju-si
country: Korea, Republic of
facility: Site KR82013
state: Gangwon-do
city: Goyang-si
country: Korea, Republic of
facility: Site KR82006
state: Gyeonggi-do
city: Jeollanam-do
country: Korea, Republic of
facility: Site KR82003
state: Hwasun-gun
city: Busan
country: Korea, Republic of
facility: Site KR82011
city: Daegu
country: Korea, Republic of
facility: Site KR82010
city: Incheon
country: Korea, Republic of
facility: Site KR82001
city: Seoul
country: Korea, Republic of
facility: Site KR82004
city: Seoul
country: Korea, Republic of
facility: Site KR82005
city: Seoul
country: Korea, Republic of
facility: Site KR82009
city: Seoul
country: Korea, Republic of
facility: Site KR82007
Study officials:
affiliation: Astellas Pharma Korea, Inc.
name: Astellas Pharma Korea, Inc.
role: STUDY_DIRECTOR
References: