UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007345 |
|---|---|
| Receipt number | 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 18:09:08 |
* 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
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
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
mizuta@mb.ccnw.ne.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
Japan
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
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
Value
https://center6.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 |
