UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059800 |
|---|---|
| Receipt number | R000068375 |
| Scientific Title | Multicenter observational study evaluating minimal residual disease in adult acute myeloid leukemia treatment -FBMTG AML-MRD- |
| Date of disclosure of the study information | 2025/11/17 |
| Last modified on | 2025/11/17 11:28:17 |
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Basic information
Public title
Multicenter observational study evaluating minimal residual disease in adult acute myeloid leukemia treatment -FBMTG AML-MRD-
Acronym
FBMTG AML-MRD
Scientific Title
Multicenter observational study evaluating minimal residual disease in adult acute myeloid leukemia treatment -FBMTG AML-MRD-
Scientific Title:Acronym
FBMTG AML-MRD
Region
| Japan |
Condition
Condition
Acute Myeloid Leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, MRD measurements will be performed at the time of initial onset, after completion of each regimen or after completion of chemotherapy, and before allogeneic hematopoietic stem cell transplantation, to verify the significance of MRD measurements in AML treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between the presence or absence of MRD and survival rate/recurrence rate
Key secondary outcomes
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) AML patients aged 18 to 85 years at the time of consent
2) Patients undergoing initial treatment who have not received chemotherapy or radiation therapy
3) AML patients morphologically diagnosed as AML M0, 1, 2, 4, 5, 6, or 7
4) Patients who have provided written informed consent for this study after receiving an explanation.
Key exclusion criteria
Cases that the attending physician judged to be inappropriate
Target sample size
300
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
12-8582
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
Nippon Shinyaku Co., Ltd.
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
| 2025 | Year | 11 | Month | 17 | 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
| 2025 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The basic treatment for acute myeloid leukemia (AML) is high-dose chemotherapy with multiple drugs. As per the algorithm recommended by the Japanese Society of Hematology, patients are stratified into good, intermediate, and poor prognosis groups according to the European LeukemiaNet (ELN) risk classification, and treatment is administered accordingly. In recent years, novel therapeutic agents, such as the anti-CD33 antibody gemtuzumab ozogamicin (GO), FLT3 inhibitors, and IDH inhibitors, have been developed and are recommended in the National Comprehensive Cancer Network (NCCN) guidelines. GO and FLT3 inhibitors have also been approved for insurance coverage in Japan. Furthermore, a liposomal formulation of the existing drugs cytarabine and daunorubicin, combined at the ratio that maximizes antitumor efficacy, is now available in Japan. This study is a prospective observational study aimed to gather information on the efficacy and safety of available treatments in Japan based on the above background.
In previous studies of other hematopoietic malignancies, such as acute lymphoblastic leukemia (ALL), determining treatment strategies based on the presence or absence of measurable residual disease (MRD) has become a fundamental approach. In ALL, residual tumor can be detected at a 10-5 level using systems such as polymerase chain reaction (PCR) to detect leukemia-specific DNA or chimeric mRNA, and treatment strategies are determined based on this. Meanwhile, in AML, MRD measurement systems have been developed, such as leukemia-associated immunophenotypes (LAIPs) and PCR-based gene mutation detection, but the timing and usefulness of measurement during treatment remain unclear. In this study, we will measure MRD at the time of initial diagnosis, at the completion of each regimen, or after chemotherapy, prior to allogeneic hematopoietic stem cell transplantation, to examine the significance of MRD measurement in AML treatment.
Management information
Registered date
| 2025 | Year | 11 | Month | 17 | Day |
Last modified on
| 2025 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068375
