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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04691648
Study type Observational
Source Astellas Pharma Inc
Contact Astellas Pharma Korea, Inc.
Phone +82 (0)10-5254-3389
Email Astellas.registration@astellas.com
Status Recruiting
Phase
Start date June 17, 2022
Completion date May 31, 2025

See also
  Status Clinical Trial Phase
Completed NCT03730012 - A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML) Phase 1/Phase 2
Active, not recruiting NCT03182244 - A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation Phase 3
Active, not recruiting NCT02752035 - A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy Phase 3