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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007345
Receipt No. R000008650
Scientific Title A phase 2 study of mid-term compliance and effectiveness of dasatinib therapy in patients with chronic myeloid leukemia.
Date of disclosure of the study information 2012/03/01
Last modified on 2016/02/21

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Basic information
Public title A phase 2 study of mid-term compliance and effectiveness of dasatinib therapy in patients with chronic myeloid leukemia.
Acronym DARIA 01 Trial
Scientific Title A phase 2 study of mid-term compliance and effectiveness of dasatinib therapy in patients with chronic myeloid leukemia.
Scientific Title:Acronym DARIA 01 Trial
Region
Japan

Condition
Condition Chronic myeloid leukemia chronic phase
Classification by specialty
Medicine in general Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To find out factors that influence the compliance and effectiveness of dasatinib therapy for patients with chronic myeloid leukemia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Compliance of dasatinib therapy at 12 months for patients with chronic myeloid leukemia.
Key secondary outcomes Treatment related toxicity (TRT)
Relationship between serum concentration of Dasatinib and clinical result (TRT, Complete Cytogenetical remission rate,Major molecular Remission rate,Complete molecular remission)
Overall survival rate at 1 year
Progression free survival at 1 year

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. CML-CP
2. Age>15 years old
3. PS 0-2 (ECOG)
4. Adequate hepatic, renal, pulmonary and cardiac function
5. ECG QTc<0.45msec
6. Written informed consent
Key exclusion criteria 1. Pregnant and/or lactating woman
2. Other active neoplasms
3. History of sever bleeding tendency
4. Psychological disorders
5. Recent history of ischemic heart disease
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuichi Mizuta
Organization Fujita Health University
Division name Department of Hematology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake
TEL 0562-93-9243
Email mizuta@mb.ccnw.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuichi Mizuta
Organization Fujita Health University
Division name Department of Hematology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake
TEL 0562-93-9243
Homepage URL
Email mizuta@mb.ccnw.ne.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 Japan

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 藤田保健衛生大学(愛知県)安城更生病院(愛知県)江南厚生病院(愛知県)

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 01 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
2012 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2014 Year 09 Month 01 Day
Date of closure to data entry
2014 Year 10 Month 01 Day
Date trial data considered complete
2014 Year 12 Month 01 Day
Date analysis concluded
2014 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 02 Month 21 Day
Last modified on
2016 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008650

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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