UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006358 |
|---|---|
| Receipt number | R000007113 |
| Scientific Title | Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia |
| Date of disclosure of the study information | 2011/09/16 |
| Last modified on | 2015/03/16 16:49:25 |
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Basic information
Public title
Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia
Acronym
IMIDAS(Inter-Michinoku dasatinib study) 1st Line
Scientific Title
Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia
Scientific Title:Acronym
IMIDAS(Inter-Michinoku dasatinib study) 1st Line
Region
| Japan |
Condition
Condition
Chronic Myeloid Leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
A Major molecular response(MMR)rate at 12 months after the intiation of Dasatinib in newly diagnosed Chronic-Phase Chronic Myeloid Leukemia
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A Major molecular response(MMR)rate at 12 months after the intiation of Dasatinib treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dasatinib will be administered at 100mg once daily for 12 months.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Newly Diagnosed Chronic-phase Chronic Myeloid Leukemia
Key exclusion criteria
Previous treatment with TKI or INF
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoji Ishida |
Organization
Iwate Medical Unversity,Internal Medicine
Division name
hematology/oncology
Zip code
Address
Uchimaru19-1, Morioka,Japan
TEL
0196515111
yishida@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KAZUNORI MURAI |
Organization
Iwate Medical Unversity,Internal Medicine
Division name
hematology/oncology
Zip code
Address
Uchimaru19-1, Morioka,Japan
TEL
0196515111
Homepage URL
kmurai@iwate-med.ac.jp
Sponsor or person
Institute
Epidemiological and Clinical Research Information Network(ECRIN)
Institute
Department
Personal name
Funding Source
Organization
Epidemiological and Clinical Research Information Network(ECRIN)
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
Address
Tel
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
| 2011 | Year | 09 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 16 | Day |
Last modified on
| 2015 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007113
