NCT04691648Completed
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
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
Source: ClinicalTrials.gov · Last updated 31 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 33 (actual)
- First submitted
- 30 Dec 2020
- Start date
- 17 Jun 2022
- Primary completion date
- 4 May 2025
- Lead sponsor
- Astellas Pharma Korea, Inc.
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT04691648
What you commit to
- Study type: Observational
- Participants enrolled: 33
- From 17 Jun 2022 to the primary completion date, 4 May 2025
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who use the drug for an off-label purpose.
Other
- Patients who meet the section 'Do not administer to the following patients' in the precautions for use given at the time of marketing authorization.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Jeollanam-do | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Wŏnju | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.