UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027961 |
|---|---|
| Receipt number | R000032029 |
| Scientific Title | JALSG AML/MDS/CMML Clinical Observational Study (JALSG-CS)-17 |
| Date of disclosure of the study information | 2017/06/29 |
| Last modified on | 2024/07/11 14:14:41 |
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Basic information
Public title
JALSG AML/MDS/CMML Clinical Observational Study (JALSG-CS)-17
Acronym
JALSG-CS-17
Scientific Title
JALSG AML/MDS/CMML Clinical Observational Study (JALSG-CS)-17
Scientific Title:Acronym
JALSG-CS-17
Region
| Japan |
Condition
Condition
AML(acute myeloid leukemia and related neoplasms),MDS(myelodysplastic syndromes),CMML(chronic myelomonocytic leukemia)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the influence of the treatment contents and complications on survival rate by clarifying the 5-year overall survival rate of AML, MDS and CMML in JALSG participating institutions.
Basic objectives2
Others
Basic objectives -Others
5-year overall survival rate for AML
5-year overall survival rate for MDS
5-year overall survival rate for CMML
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
5-year overall survival rate for AML
5-year overall survival rate for MDS
5-year overall survival rate for CMML
Key secondary outcomes
(1)Remission rate and survival rate in each therapy of initial induction therapy and re-induction therapy for AML.
(2)Influence of use/non-use of azacitidine and gemutuzumab ozogamicin on survival rate in AML.
(3)Remission rate and survival rate in each initial therapy using azacitidine in MDS.
(4)Use/Non-use of lenalidomide, deferasirox and erythropoietin, and survival rate in MDS.
(5)Remission rate and survival rate in each initial therapy using azacitidine in CMML.
(6)Influence of situation at the time of allogeneic hematopoietic stem cell transplantation, and of presence/absence of donor source and family donor on survival rate.
(7)Influence of comorbidity (by Charlson comorbidity index) on treatment outcome.
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)Aged 16 or older with all newly diagnosed untreated AML, MDS, CMML at participating institutions.
(2)Diseases are defined in accordance with WHO classification, 2016 edition.
(3)Acute leukemias of ambiguous lineage (acute undifferentiated leukemia, mixed phenotype acute leukemia (MPAL)) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) are also included, except MDS/MPN other than CMML.
In order to strictly apply the WHO classification 2016 edition, following examinations are required in addition to the commonly performed chromosome examination: SF3B1 mutation in MDS, NPM1 mutation in AML, double CEBPA mutation, and RUNX1 mutation. Confirming that the presence or absence of history of these genetic examinations, classification is made on the assumption that there is no mutation for the case of absence. In the case of diagnosing AML with myelodysplasia-related changes (AML-MRC) based on the preceding hematopoietic abnormality, it is assumed that a hematopoietic abnormality period of 3 months or more has been confirmed.
Key exclusion criteria
(1)With a history of chemotherapy or hematopoietic stem cell transplantation in AML, MDS or CMML; however, treatment-related AML, MDS and CMML which developed after the following therapies are included: therapy for preceding blood abnormalities (such as immunosuppressive therapy for aplastic anemia), chemotherapy for malignancy of other tissues, radiation therapy (such as radiation therapy for preceding breast cancer, chemotherapy for preceding malignant lymphoma).
(2)In case of progress from MDS or CMML to AML, re-registration is not required if it is registered with preceding MDS or CMML. MDS and CMML which had already been diagnosed outside the JALSG participating institutions are excluded. The case which developed to AML after having been diagnosed as MDS by other than those institutions and transferred to the own institution is registered as AML (with preceding blood disease). (Even if the history of abnormality of blood count is long, newly diagnosed MDS and CMML in the own institution are not excluded.)
Target sample size
4900
Research contact person
Name of lead principal investigator
| 1st name | Hisayuki |
| Middle name | |
| Last name | Yokoyama |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Hematology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai-shi, 980-8574, Japan
TEL
022-717-7165
hisayuki.yokoyama.a1@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hisayuki |
| Middle name | |
| Last name | Yokoyama |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Hematology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai-shi, 980-8574, Japan
TEL
022-717-7165
Homepage URL
http://www.jalsg.jp/
hisayuki.yokoyama.a1@tohoku.ac.jp
Sponsor or person
Institute
Japan Adult Leukemia Study Group (JALSG)
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2017 | Year | 06 | Month | 29 | 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
6542
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
| 2017 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary outcomes
5-year overall survival rate for AML
5-year overall survival rate for MDS
5-year overall survival rate for CMML
Secondary outcomes
(1)Remission rate and survival rate in each therapy of initial induction therapy and re-induction therapy for AML.
(2)Influence of use/non-use of azacitidine and gemutuzumab ozogamicin on survival rate in AML.
(3)Remission rate and survival rate in each initial therapy using azacitidine in MDS.
(4)Use/Non-use of lenalidomide, deferasirox and erythropoietin, and survival rate in MDS.
(5)Remission rate and survival rate in each initial therapy using azacitidine in CMML.
(6)Influence of situation at the time of allogeneic hematopoietic stem cell transplantation, and of presence/absence of donor source and family donor on survival rate.
(7)Influence of comorbidity (by Charlson comorbidity index) on treatment outcome.
Management information
Registered date
| 2017 | Year | 06 | Month | 28 | Day |
Last modified on
| 2024 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032029
