UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039778 |
|---|---|
| Receipt number | R000045336 |
| Scientific Title | Study for the Sensitivity of Gilteritinib in Acute Myeloid Leukemia |
| Date of disclosure of the study information | 2020/03/16 |
| Last modified on | 2024/03/14 14:23:16 |
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Basic information
Public title
Study for the Sensitivity of Gilteritinib in Acute Myeloid Leukemia
Acronym
Study for the Sensitivity of Gilteritinib in Acute Myeloid Leukemia
Scientific Title
Study for the Sensitivity of Gilteritinib in Acute Myeloid Leukemia
Scientific Title:Acronym
Study for the Sensitivity of Gilteritinib in Acute Myeloid Leukemia
Region
| Japan |
Condition
Condition
Acute Myeloid Leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The primary object is to determine the factors involved in the sensitivity of gilteritinib in relapsed or refractory FLT3 mutation-positive AML by evaluating treatment response, molecular pathology of leukemia cells, and plasma inhibitory activity assay.
Basic objectives2
Others
Basic objectives -Others
To elucidate mechanisms of gilteritinib resistance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between plasma inhibitory activity (PIA) and best response during the treatment in the patients who are treated with gilteritinib
Key secondary outcomes
1. Relationship between the efficacy of gilteritinib and gene mutations
2.Correlation between the efficacy of gilteritinib and minimal residual disease
3.Relationship between PIA and gilteritinib blood levels
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Subject is relapsed / refractory AML.
2.Subject is positive for FLT3 gene mutation and scheduled to receive gilteritinib.
3.Subject with written consent to participate in this study.
Key exclusion criteria
1. Subject has difficulty to give written consent.
2. Subject is judged to be inappropriate for this study by the investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kiyoi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Hematology and Oncology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2145
kiyoi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Ishikawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Hematology and Oncology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2145
Homepage URL
yishikaw@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Hematology and Oncology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-741-2111
iga-shinsa@adm.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Registration period is from April 1, 2020 to March 31, 2023
Subject selection: Patients who visited the study site and met the selection criteria of this study
Following clinical information will be collected: Date of birth, gender, diagnosis/ relapse date, FAB classification, WHO classification, chromosome data, peripheral complete blood cell count, presence / absence of gene mutation, bone marrow / peripheral blast ratio, patient co-morbidity, treatment, survival, death, outcome of recurrence, and cause of death
Management information
Registered date
| 2020 | Year | 03 | Month | 11 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045336
