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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001900
Receipt No. R000002308
Scientific Title PhaseII study of Dasatinib in patients with chronic myeloid leukemia after Imatinib failure
Date of disclosure of the study information 2009/04/23
Last modified on 2012/04/23

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Basic information
Public title PhaseII study of Dasatinib in patients with chronic myeloid leukemia after Imatinib failure
Acronym PhaseII study of Dasatinib in patients with chronic myeloid leukemia after Imatinib failure
Scientific Title PhaseII study of Dasatinib in patients with chronic myeloid leukemia after Imatinib failure
Scientific Title:Acronym PhaseII study of Dasatinib in patients with chronic myeloid leukemia after Imatinib failure
Region
Japan

Condition
Condition Chronic Myeloid Leukemia (chronic phase)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Efficacy and safety of Dasatinib in Japanese CML patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes MMR rate
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dasatinib
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
15 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria Imatinib failure
above 15 years old
PS 0-2
Key exclusion criteria double cancer
pregnancy

etc
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,Moriaka,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Iwate Medical University
Division name hematology/oncology
Zip code
Address Uchimaru19-1,Morioka,Japan
TEL
Homepage URL
Email

Sponsor
Institute Inter-Michinoku Dasatinib Study(IMIDAS)
Institute
Department

Funding Source
Organization Inter-Michinoku Dasatinib Study(IMIDAS)
Organization
Division
Category of Funding Organization Self funding
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
2009 Year 04 Month 23 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 Completed
Date of protocol fixation
2009 Year 02 Month 21 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2011 Year 10 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 04 Month 23 Day
Last modified on
2012 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002308

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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