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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

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

Trial locations and contacts

10 sites in 1 country.

About this study

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

Conditions

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

Being tested

Gilteritinib Exposure

Keywords

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

Medical subject headings

Recurrence, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Gilteritinib ExposureDrug

  Also called Xospata

  Oral

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

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

2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted31 Dec 2020
2. Study start17 Jun 2022
3. Primary completion4 May 2025
4. Study completion4 May 2025

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) MutationStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.