Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan

Phase II Clinical Trial of Dasatinib First Line Therapy for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

The purpose of this study is to evaluate effectiveness of Dasatinib as the first line therapy for patients with newly diagnosed chronic myeloid leukemia in chronic phase in Japan.

Inclusion Criteria:

• Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase
• 20 years old over
• ECOG performance status (PS) score 0-2
• 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 whithin 6 months
  • have an Angina within 3 months
  • have a Congestive heart failure within 3 months
  • 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