A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib
NCT ID: NCT01342679
Last Updated: 2015-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
21 participants
INTERVENTIONAL
2011-04-30
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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dasatinib
dasatinib
100mg QD
Interventions
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dasatinib
100mg QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 20 years old over
* ECOG performance status (PS) score 0-2
* Patients for major molecular response (MMR) with no CMR
* Adequate organ function (hepatic, renal and lung)
* Signed written informed consent
Exclusion Criteria
* Women who are pregnant or breastfeeding
* The case of Pleural effusion clearly
* Patients with complications or a history of severe or uncontrolled cardiovascular failure following
* have a Myocardial infarction within 6 months
* have an Angina within 3 months
* have a Congestive heart failure within 3 months
* have a suspected congenital QT syndrome
* have a QTc interval of more than 450msec at baseline
* A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
* Prior treatment with dasatinib
* Subjects with T315I, F317L and V299L BCR-ABL point mutations
20 Years
ALL
No
Sponsors
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Epidemiological and Clinical Research Information Network
OTHER
Kanto CML Study Group
OTHER
Responsible Party
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Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Principal Investigators
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Chikashi Yoshida, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Hospital Organization, Mito Medical Center
Locations
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Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, Japan
Countries
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Other Identifiers
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KCSG-02
Identifier Type: -
Identifier Source: org_study_id
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