Chronic Myeloid Leukemia
Conditions
Keywords
chronic myeloid leukemia, dasatinib, chronic phase myeloid leukemia
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 mesylate.
Interventions
DRUGdasatinib
100mg QD
Sponsors
Epidemiological and Clinical Research Information Network
Kanto CML Study Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed Written Informed Consent * Subjects with chronic phase chronic myeloid leukemia (CML) * Subjects resistant/intolerant to imatinib * Subjects presenting: 1. ECOG performance status (PS) score 0-2 2. Adequate hepatic function 3. Adequate renal function 4. Adequate lung function
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects | at 12 months |
Secondary
| Measure | Time frame |
|---|---|
| safety after treatment with dasatinib | 2 year |
| rate of Complete Cytogenetic Response(CCyR) | 2 year |
| rate of Complete Hematologic Response (CHR) | 2 year |
| efficacy on patients with BCR-ABL point mutations | 2 year |
| progression free survival | 2 year |
Countries
Japan
Outcome results
None listed