Status:
UNKNOWN
Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan
Lead Sponsor:
Kanto CML Study Group
Conditions:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelogenous Leukemia, Chronic, Chronic Phase
Eligibility:
All Genders
20+ years
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01464411
Start Date
July 1 2011
Last Update
November 3 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kanto CML Study Group
Tokyo, Japan