A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate complete molecular response of Dasatinib in patients for Philadelphia chromosome-positive chronic myeloid leukemia

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kanto CML Study Group
• Collaborator: Epidemiological and Clinical Research Information Network
• Treatments: Dasatinib

Criteria

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