UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036437 |
|---|---|
| Receipt number | R000041518 |
| Scientific Title | JALSG AML/MDS/CMML Clinical Observational Study(JALSG-CS-11-MDS-SCT) |
| Date of disclosure of the study information | 2019/04/07 |
| Last modified on | 2019/04/07 20:37:40 |
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Basic information
Public title
JALSG AML/MDS/CMML Clinical Observational Study(JALSG-CS-11-MDS-SCT)
Acronym
JALSG AML/MDS/CMML Clinical Observational Study(JALSG-CS-11-MDS-SCT)
Scientific Title
JALSG AML/MDS/CMML Clinical Observational Study(JALSG-CS-11-MDS-SCT)
Scientific Title:Acronym
JALSG AML/MDS/CMML Clinical Observational Study(JALSG-CS-11-MDS-SCT)
Region
| Japan |
Condition
Condition
MDS-RAEB/EB
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify an optimal bridging therapy between the diagnosis and the allogeneic hematopoietic stem cell transplantation in patients with myelodysplastic syndromes registered as JALSG-CS-11.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival by bridging therapy
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
| Not applicable |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
MDS-RAEB/EB patients registered as JALSG-CS-11 between 2011 and 2016.
Key exclusion criteria
None
Target sample size
491
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Ishiyama |
Organization
Kanazawa University Hospital
Division name
Department of Hematology
Zip code
920-8641
Address
13-1 Takaramachi, Kanazawa, Ishikawa 920-8641, Japan
TEL
076-265-2274
ishiyama-knz@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Ishiyama |
Organization
JALSG-CS-11-MDS-SC research secretariat
Division name
Department of Hematology
Zip code
920-8641
Address
13-1 Takaramachi, Kanazawa, Ishikawa 920-8641, Japan
TEL
076-265-2274
Homepage URL
https://www.jalsg.jp/
ishiyama-knz@umin.ac.jp
Sponsor or person
Institute
Japan Adult Leukemia Study Group(JALSG)
Institute
Department
Personal name
Funding Source
Organization
Japan Adult Leukemia Study Group(JALSG)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Innovative Clinical Research Center, Kanazawa University.
Address
13-1 Takaramachi, Kanazawa, Ishikawa 920-8641, Japan
Tel
076-265-2090
crc.irb-knz@esct.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
| 2019 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Overall survival by bridging therapy
Management information
Registered date
| 2019 | Year | 04 | Month | 07 | Day |
Last modified on
| 2019 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041518
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
