UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061136 |
|---|---|
| Receipt number | R000069656 |
| Scientific Title | An observational study to evaluate the impact of treatment strategies and patient-related factors on survival in patients with newly diagnosed Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), and Chronic Myelomonocytic Leukemia (CMML) at institutions participating in the Japan Adult Leukemia Study Group (JALSG) |
| Date of disclosure of the study information | 2026/04/02 |
| Last modified on | 2026/04/02 11:58:46 |
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Basic information
Public title
An observational study to evaluate the impact of treatment strategies and patient-related factors on survival in patients with newly diagnosed Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), and Chronic Myelomonocytic Leukemia (CMML) at institutions participating in the Japan Adult Leukemia Study Group (JALSG)
Acronym
JALSG-CS-25
Scientific Title
An observational study to evaluate the impact of treatment strategies and patient-related factors on survival in patients with newly diagnosed Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), and Chronic Myelomonocytic Leukemia (CMML) at institutions participating in the Japan Adult Leukemia Study Group (JALSG)
Scientific Title:Acronym
JALSG-CS-25
Region
| Japan |
Condition
Condition
Patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or chronic myelomonocytic leukemia (CMML) diagnosed at institutions participating in the Japan Adult Leukemia Study Group (JALSG).
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This is a multicenter prospective observational study based on a centralized registry that collects clinical and biomarker data from patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or chronic myelomonocytic leukemia (CMML) diagnosed at institutions participating in the Japan Adult Leukemia Study Group (JALSG). The study aims to determine the 3- and 5-year survival rates and to evaluate the associations between treatment outcomes, treatment strategies, and patient-related factors such as age and comorbidities.
Basic objectives2
Others
Basic objectives -Others
In addition to assessing overall survival in all registered patients, the primary objective is to collect data on factors potentially associated with treatment outcomes, including (1) disease characteristics at diagnosis, including hematologic malignancy panel testing results; (2) treatment regimens used in real-world clinical practice; (3) the use of novel agents such as venetoclax, gemtuzumab ozogamicin (GO), azacitidine, lenalidomide, FLT3 inhibitors, CPX-351, and IDH inhibitors, as well as supportive therapies including iron chelation and erythropoiesis-stimulating agents; (4) allogeneic hematopoietic stem cell transplantation; (5) comorbidities; and (6) geriatric-specific factors, in order to generate evidence that may contribute to improving future prognosis.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival of patients with AML, MDS, or CMML
Key secondary outcomes
Initial treatment efficacy and remission rates by treatment type for AML, MDS, and CMML
Relapse-free survival by AML, MDS, and CMML
Impact of the use of new drugs on survival rates for AML, MDS, and CMML
Impact of the use of supportive care medications on survival rates for AML, MDS, and CMML
Evaluation of causes of death
Survival rates following allogeneic hematopoietic stem cell transplantation, and the relationship between transplantation methods and relapse-free and graft-versus-host disease (GVHD)-free survival rates
Evaluation of transplantation-related complications in allogeneic hematopoietic stem cell transplantation cases
Analysis of risk factors affecting overall survival (OS) (impact of patient background, comorbidities, and concomitant medications on treatment outcomes)
Impact of genetic information on prognosis
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
Age >16 years at the time of informed consent.
Newly diagnosed and previously untreated AML (acute myeloid leukemia and related neoplasms), MDS (myelodysplastic syndromes), or CMML (chronic myelomonocytic leukemia) according to the Revised 4th Edition of the WHO Classification.
Patients with acute leukemias of ambiguous lineage (acute undifferentiated leukemia and mixed phenotype acute leukemia [MPAL]) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) are also eligible.
MDS/MPN (myelodysplastic/myeloproliferative neoplasms) other than CMML are excluded.
After receiving a full explanation regarding participation in this study, written informed consent was obtained from the patient (or, in the case of minors or adults with impaired capacity to consent due to cognitive decline, from a legal representative, or from both the patient and the legal representative) based on their full understanding and of their own free will.
Key exclusion criteria
If the principal investigator or a co-investigator determines that participation in this study is inappropriate.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Emiko |
| Middle name | |
| Last name | Sakaida |
Organization
Chiba University Hospital
Division name
Department of Hematology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
0432227171
ketsueki@office.chiba-u.jp
Public contact
Name of contact person
| 1st name | Emiko |
| Middle name | |
| Last name | Sakaida |
Organization
Chiba University Hospital
Division name
Department of Hematology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
0432227171
Homepage URL
https://www.jalsg.jp/
ketsueki@office.chiba-u.jp
Sponsor or person
Institute
JALSG
Institute
Department
Personal name
Funding Source
Organization
JALSG Astellas
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board (IRB), National Hospital Organization Nagoya Medical Center
Address
4-1-1 Sannomaru, Naka-ku, Nagoya
Tel
052-951-1111
311-rec@mail.hosp.go.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
| 2026 | Year | 04 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2032 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2032 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2033 | Year | 05 | Month | 31 | Day |
Other
Other related information
Clinical information obtained during routine medical care at diagnosis, during treatment, and after treatment for each disease will be collected.
Management information
Registered date
| 2026 | Year | 04 | Month | 02 | Day |
Last modified on
| 2026 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069656
