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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006517
Receipt No. R000007727
Scientific Title A study of the relationship between dasatinib medication for chronic myeloid leukemia in chronic phase and vascular endothelial function related and immunological parameters.
Date of disclosure of the study information 2011/10/11
Last modified on 2011/10/11

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Basic information
Public title A study of the relationship between dasatinib medication for chronic myeloid leukemia in chronic phase and vascular endothelial function related and immunological parameters.
Acronym A study of the relationship between dasatinib medication for chronic myeloid leukemia in chronic phase and vascular endothelial function related and immunological parameters.
Scientific Title A study of the relationship between dasatinib medication for chronic myeloid leukemia in chronic phase and vascular endothelial function related and immunological parameters.
Scientific Title:Acronym A study of the relationship between dasatinib medication for chronic myeloid leukemia in chronic phase and vascular endothelial function related and immunological parameters.
Region
Japan

Condition
Condition chronic myeloid leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To find predictors of adverse drug reactions from medication of dasatinib hydrate, in the patients with newly diagnosed chronic myeloid leukemia in chronic phase, to take it safely.
Basic objectives2 Others
Basic objectives -Others To find immunological function of this drug during treatment.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Examine the relationship between occurrence of pleural effusion caused by dasatinib medication and levels of angiopoietin-2 in plasma.
Key secondary outcomes 1) Examine the relationship between dasatinib medication and occurrence of pleural effusion by vascular endothelial function related parameters and by immunological parameters.
2) Examine the relationship between dasatinib medication and thrombocytopenia by vascular endothelial function related parameters and by immunological parameters.

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 Patients will take 100 mg of dasatinib once daily at the same time each day.
The daily dosage may be increased up to 140 mg according to the patient's condition.
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 1) De novo chronic myeloid leukemia patients in chronic phase (Who meet all the conditions listed below)
Less than 15% myeloblasts in the bone marrow
Less than 30% myeloblasts plus promyelocytes in the bone marrow
Less than 20% basophils in the peripheral blood
Platelet counts of 100,000 / mm3 or more
Absence of extramedullary disease except for hepatosplenomegaly
Cells carrying Ph chromosome or its variant confirmed by bone marrow cytogenetics test
2) Patients have an ECOG performance status of 0 to 2
3) Patients with adequate hepatic, renal and pulmonary function
AST and ALT less than 5 times the institutional upper limit, with total bilirubin less than 3 times the institutional upper limit
Serum creatinine level less than 3 times the institutional upper limit
PaO2 greater than 60 mmHg by arterial blood gas analysis, or SpO2 not below than 93% by pulse oximeter, while breathing room air
4) Patients have received no previous treatment for CML except for hydroxyurea
5) Signed written informed consent
Key exclusion criteria Patients who meet any of the following criteria will be excluded from this study
1) Presence of any other active neoplasm
2) Pregnant and lactating woman
3) Whom the investigator considered inappropriate to this study
4) Presence of apparent pleural effusion
5) Patients with complication or history of serious or poor-controlled cardiovascular disorders as below
Cardiac infarction within 6 months
Angina pectoris within 3 months
Congestive heart failure within 3 months
Suspicion of a congenital long QT syndrome
QTc interval prolongation (adjusted according to Fridericia's formula) on the electrocardiogram exceed 450 msec at baseline
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shosaku Nomura
Organization Kansai Medical University
Division name First Department of Internal Medicine
Zip code
Address 10-15 Fumizono-cho, Moriguchi city, Osaka
TEL 06-6993-9453
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomoki Ito
Organization Kansai Medical University
Division name First Department of Internal Medicine
Zip code
Address 10-15 Fumizono-cho, Moriguchi city, Osaka
TEL 06-6993-9457
Homepage URL
Email itot@takii.kmu.ac.jp

Sponsor
Institute Kansai CML-Clinical Study Group
Institute
Department

Funding Source
Organization First department of internal medicine, Kansai medical university
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kansai CML-Clinical Study Group
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 関西医科大学(大阪府)
関西医科大学附属枚方病院(大阪府)
関西医科大学附属滝井病院(大阪府)
松下記念病院(大阪府)
市立岸和田市民病院(大阪府)
医仁会武田総合病院(京都府)
枚方公済病院(大阪府)
独立行政法人国立病院機構大阪南医療センター(大阪府)
近畿大学医学部堺病院(大阪府)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 11 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 Preinitiation
Date of protocol fixation
2011 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 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 10 Month 11 Day
Last modified on
2011 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007727

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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