Dasatinib for Patients Achieving Complete Molecular Response for Cure D-NewS Trial

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission(CMR) while on dasatinib.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kanto CML Study Group
• Treatments: Dasatinib

Criteria

Inclusion Criteria:

• Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase

• 15 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.

• female patient who there is not intention with an appropriate sterilization, or cannot use it during a study entry period

• 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 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