UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006517
Receipt number 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 11:01:18

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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 or person

Institute

Kansai CML-Clinical Study Group

Institute

Department

Personal name



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

Value
https://center6.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