Leukemia, Lymphocytic, Acute, L2, Leukemia, Myeloid, Chronic
Conditions
Keywords
Chronic Myeloid Leukemia Accelerated and Blast Phase, Leukemia, Acute, Philadelphia-Positive
Brief summary
The purpose of this clinical research study is to provide dasatinib treatment to patients with advanced chronic myelogenous leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who no longer can tolerate treatment with imatinib. The safety of the treatment will also be studied.
Interventions
DRUGDasatinib
Tablets, Oral, 70 mg, Twice daily, 2 months.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of accelerated phase or blast phase CML or Ph+ ALL * Intolerant or resistant to imatinib mesylate * 18 years of age or older * ECOG performance 0-2 (greater than 50% of time out of bed) * Adequate liver and kidney function
Exclusion criteria
* Pregnant or breastfeeding females * History of significant cardiac disease * History of significant bleeding disorder (not CML) * Prisoners
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Provide therapy to patients for which there is no therapeutic alternative | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety data collection | — |
Countries
Canada, United States
Outcome results
None listed