Status:
COMPLETED
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
Lead Sponsor:
Astellas Pharma Korea, Inc.
Conditions:
Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
Eligibility:
All Genders
18+ years
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 pra...
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 mutat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 4 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04691648
Start Date
June 17 2022
End Date
May 4 2025
Last Update
May 31 2025
Active Locations (10)
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1
Site KR82013
Wŏnju, Gangwon-do, South Korea, 26426
2
Site KR82006
Goyang-si, Gyeonggi-do, South Korea, 10408
3
Site KR82003
Jeollanam-do, Hwasun-gun, South Korea, 58128
4
Site KR82011
Busan, South Korea, 47392