Status:
UNKNOWN
Dasatinib for Patients Achieving Complete Molecular Response for Cure D-NewS Trial
Lead Sponsor:
Kanto CML Study Group
Conditions:
Myelogenous Leukemia, Chronic, Chronic Phase
Eligibility:
All Genders
15+ years
Phase:
PHASE2
Brief 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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01887561
Start Date
November 1 2012
Last Update
June 27 2013
Active Locations (1)
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1
National Disaster Medical Center
Tachikawa, Tokyo, Japan, 190-0014