Official Title
A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib
Phase
Phase 2Lead Sponsor
Kanto CML Study GroupStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Chronic Myeloid LeukemiaIntervention/Treatment
dasatinib ...Study Participants
21The purpose of this study is to evaluate complete molecular response of Dasatinib in patients for Philadelphia chromosome-positive chronic myeloid leukemia
100mg QD
Inclusion Criteria: Chronic Myeloid Leukemia in the Chronic Phase 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: A case with the double cancer of the activity 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
