Status:
COMPLETED
A Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia
Lead Sponsor:
Kanto CML Study Group
Collaborating Sponsors:
Epidemiological and Clinical Research Information Network
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
15+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and the safety of dasatinib in subject with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of imatinib mesy...
Eligibility Criteria
Inclusion
- Signed Written Informed Consent
- Subjects with chronic phase chronic myeloid leukemia (CML)
- Subjects resistant/intolerant to imatinib
- Subjects presenting:
- ECOG performance status (PS) score 0-2
- Adequate hepatic function
- Adequate renal function
- Adequate lung function
Exclusion
- Concurrent malignancy other than CML
- Women who are pregnant or breastfeeding
- Concurrent pleural effusion
- Uncontrolled or significant cardiovascular disease
- A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy.
- Prior therapy with dasatinib
- Subjects with T315I and/or F317L BCR-ABL point mutations
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00866736
Start Date
March 1 2009
End Date
June 1 2012
Last Update
September 15 2015
Active Locations (1)
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1
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, Japan, 113-8677