UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055182 |
|---|---|
| Receipt number | R000063052 |
| Scientific Title | Study on the Effects of Gilteritinib Maintenance Therapy on Leukemia and Normal Immune Cells after Allogeneic Hematopoietic Stem Cell Transplantation |
| Date of disclosure of the study information | 2024/08/07 |
| Last modified on | 2024/08/07 11:08:46 |
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Basic information
Public title
Study to assess the Effects of Gilteritinib Maintenance Therapy on Leukemia and Normal Immune Cells after Allogeneic Hematopoietic Stem Cell Transplantation
Acronym
The Effects of Gilteritinib Maintenance Therapy after allo-HSCT for AML
Scientific Title
Study on the Effects of Gilteritinib Maintenance Therapy on Leukemia and Normal Immune Cells after Allogeneic Hematopoietic Stem Cell Transplantation
Scientific Title:Acronym
The Effects of Gilteritinib Maintenance Therapy after allo-HSCT for AML
Region
| Japan |
Condition
Condition
Acute Myeloid Leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the Efficacy and Safety of FLT3 Inhibitor (Gilteritinib) Maintenance Therapy after Allo-HSCT for AML, and Elucidation of the Immune Dynamics and Anti-Leukemic Effects Induced by Post-Transplant FLT3 Inhibitor (Gilteritinib) Maintenance Therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the Dynamics of AML and Immune Cells
Key secondary outcomes
1. Measurement of minimal residual disease (MRD) by multicolor flow cytometry
2. Incidence of acute and chronic GVHD
3. Relapse rate after allogeneic transplantation
4. Non-relapse mortality rate after allogeneic transplantation
5. Disease-free survival rate after allogeneic transplantation
6. Overall survival rate after allogeneic transplantation
7. Duration of complete remission after allogeneic transplantation
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Cases aged 18 years or older at the time of informed consent
2. Cases of refractory AML who underwent allogeneic hematopoietic stem cell transplantation between the study approval date and March 31, 2026
3. Cases with a Performance Status (ECOG) of 0 to 2
4. Cases with an expected survival of three months or more
5. Cases without severe organ dysfunction
6. Cases for which written informed consent has been obtained from the patient after explaining the study details
7. Cases for which written informed consent has been obtained from the patient regarding participation in the preceding study KCNET
Key exclusion criteria
1. Cases with active overlapping cancers
2. Cases with uncontrolled infections
3. Cases with severe psychiatric disorders
4. Cases who are pregnant or currently breastfeeding
5. Cases deemed inappropriate by the attending physician for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kato |
Organization
Kyushu University Hospital
Division name
Department of Hematology, Oncology and Cardiovascular Medicine
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5230
kato.koji.429@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuji |
| Middle name | |
| Last name | Yamauchi |
Organization
Kyushu University Hospital
Division name
Department of Hematology, Oncology and Cardiovascular Medicine
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5230
Homepage URL
yamauchi.takuji.355@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
About Institutional Review Boards / Ethics Committees of Kyushu University
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel
092-642-5082
ijkseimei@jimu.kyushu-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
| 2024 | Year | 08 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of the Efficacy and Safety of FLT3 Inhibitor (Gilteritinib) Maintenance Therapy after Allo-HSCT for AML, and Elucidation of the Immune Dynamics and Anti-Leukemic Effects Induced by Post-Transplant FLT3 Inhibitor (Gilteritinib) Maintenance Therapy
Management information
Registered date
| 2024 | Year | 08 | Month | 07 | Day |
Last modified on
| 2024 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063052
