UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006358
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kmurai@iwate-med.ac.jp

Sponsor
Institute Epidemiological and Clinical Research Information Network(ECRIN)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007113

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.