UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005843 |
|---|---|
| Receipt number | R000006906 |
| Scientific Title | A Multi-center Phase II Study evaluating efficacy and safety of Dasatinib in Patients with newly diagnosed Philadelphia(Ph) chromosome positive Chronic Myeloid Leukemia in chronic phase. |
| Date of disclosure of the study information | 2011/06/24 |
| Last modified on | 2024/07/03 09:05:05 |
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Basic information
Public title
A Multi-center Phase II Study evaluating efficacy and safety of Dasatinib in Patients with newly diagnosed Philadelphia(Ph) chromosome positive Chronic Myeloid Leukemia in chronic phase.
Acronym
A Multi-center Phase II Study evaluating efficacy and safety of Dasatinib.
Scientific Title
A Multi-center Phase II Study evaluating efficacy and safety of Dasatinib in Patients with newly diagnosed Philadelphia(Ph) chromosome positive Chronic Myeloid Leukemia in chronic phase.
Scientific Title:Acronym
A Multi-center Phase II Study evaluating efficacy and safety of Dasatinib.
Region
| Japan |
Condition
Condition
Chronic Myeloid Leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study is designed to evaluate Efficacy and safety of Dasatinib 100mg QD in newly diagnosed Ph positive CML-CP patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A major molecular response(MMR) rate by 12 months after the initiation 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 100 mg after breakfast once daily for 24 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
Chronic Myeloid Leukemia in chronic phase
Key exclusion criteria
Previous treatment with TKI or IFN-alpha
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomoiku |
| Middle name | |
| Last name | Takaku |
Organization
Juntendo University School of Medicine
Division name
Department of Hematology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0338133111
ttakaku@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tomoiku |
| Middle name | |
| Last name | Takaku |
Organization
Juntendo University School of Medicine
Division name
Department of Hematology
Zip code
1138431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0338133111
Homepage URL
ttakaku@juntendo.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
Juntendo ethical comity
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
Tel
0338133111
hongo-rinri@juntendo.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
| 2011 | Year | 06 | Month | 24 | 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
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 24 | Day |
Last modified on
| 2024 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006906
