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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

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ClinicalTrials.gov Identifier: NCT04691648
Recruitment Status : Recruiting
First Posted : December 31, 2020
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )

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.

Condition or disease Intervention/treatment
Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation Drug: Gilteritinib Exposure

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 36 months according to the purpose of this study in routine clinical practice as an observational study.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : June 17, 2022
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2023


Group/Cohort Intervention/treatment
Xospata
Patients who receive Xospata® 40 mg tablet in routine clinical practice according to the drug label approved at the time of marketing authorization.
Drug: Gilteritinib Exposure
Oral
Other Name: Xospata




Primary Outcome Measures :
  1. Number of participants with Adverse Drug Reactions (ADRs) related to important identified and/or potential risks [ Time Frame: Up to a maximum of 36 months (until 30 days after the last dose) ]
    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.

  2. Number of participants with serious ADRs related to important identified and/or potential risks [ Time Frame: Up to a maximum of 36 months (until 30 days after the last dose) ]
    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.


Secondary Outcome Measures :
  1. Number of participants with ADRs related to identified risks and considered not important [ Time Frame: Up to a maximum of 36 months (until 30 days after the last dose) ]
    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 identified risks but considered not important, such as other ADRs described by the Korean package insert, 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.

  2. Number of participants with AEs [ Time Frame: Up to a maximum of 36 months (until 30 days after the last dose) ]
    An AE is defined as any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE 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. Causal relationship between the study drug is judged by medically qualified investigator either as certain, probable/likely, possible, unlikely, conditional/unclassified or unassessable/unclassifiable.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving Xospata® 40 mg tablet according to the drug label for 36 months from the start date of marketing in Korea.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04691648


Contacts
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Contact: Astellas Pharma Korea, Inc. +82 (0)10-5254-3389 Astellas.registration@astellas.com

Locations
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Korea, Republic of
Site KR82006 Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
Site KR82003 Recruiting
Jeollanam-do, Hwasun-gun, Korea, Republic of, 58128
Site KR82011 Recruiting
Busan, Korea, Republic of, 47392
Site KR82010 Recruiting
Daegu, Korea, Republic of, 41944
Site KR82001 Recruiting
Incheon, Korea, Republic of, 21565
Site KR82008 Recruiting
Seoul, Korea, Republic of, 02447
Site KR82005 Recruiting
Seoul, Korea, Republic of, 03722
Site KR82009 Recruiting
Seoul, Korea, Republic of, 05505
Site KR82002 Recruiting
Seoul, Korea, Republic of, 06351
Site KR82007 Recruiting
Seoul, Korea, Republic of, 07985
Sponsors and Collaborators
Astellas Pharma Korea, Inc.
Investigators
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Study Director: Astellas Pharma Korea, Inc. Astellas Pharma Korea, Inc.
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Responsible Party: Astellas Pharma Korea, Inc.
ClinicalTrials.gov Identifier: NCT04691648    
Other Study ID Numbers: 2215-PV-001
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: November 3, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Korea, Inc. ):
Gilteritinib
Xospata
Relapsed or refractory Acute Myeloid Leukemia (AML)
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms