Chronic Myeloid Leukemia
Conditions
Keywords
chronic myeloid leukemia, dasatinib, complete molecular response
Brief summary
The purpose of this study is to evaluate complete molecular response of Dasatinib in patients for Philadelphia chromosome-positive chronic myeloid leukemia
Interventions
DRUGdasatinib
100mg QD
Sponsors
Epidemiological and Clinical Research Information Network
Kanto CML Study Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic Myeloid Leukemia in the Chronic Phase * 20 years old over * ECOG performance status (PS) score 0-2 * Patients for major molecular response (MMR) with no CMR * 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 within 6 months * have an Angina within 3 months * have a Congestive heart failure within 3 months * have a suspected congenital QT syndrome * 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 * Prior treatment with dasatinib * Subjects with T315I, F317L and V299L BCR-ABL point mutations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of complete molecular response (CMR) after treatment with dasatinib | at 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Dasatinib of dose intensity | at 12 months |
| Expansions rate of large granular lymphocyte | at 12 months |
| Progression free survival | at 12 months |
| Number of Participants with Adverse Events | at 12 months |
Countries
Japan
Outcome results
None listed