Protocol
12-216
Full Title
A Phase 3 Randomized, Open-Label Study of Ponatinib Versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Purpose
This study is comparing the effectiveness of the investigational drug ponatinib with the established drug imatinib for treating patients with chronic myeloid leukemia (CML) in chronic phase who have not yet received treatment for the disease. Imatinib is the standard therapy for CML, but some patients eventually develop resistance to this treatment.
Ponatinib is similar to imatinib in that it decreases the number of blood cells in the body that contain the Philadelphia (Ph) chromosome, the genetic defect associated with CML. However, ponatinib has a slightly different structure than imatinib, and it is especially effective in patients who have a specific genetic abnormality (called the T315I mutation) in the protein produced by the Ph chromosome.
In this study, patients newly diagnosed with CML will be randomly assigned to receive either ponatinib or imatinib. Both drugs are taken orally (by mouth).
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must be newly diagnosed with CML in chronic phase and have confirmed presence of the Ph chromosome.
- Patients may not have had prior therapy for CML (with the exception of hydroxyurea, whch is permitted).
- Patients must be able to be ambulatory for more than half of their normal waking hours.
- This study is open to patients age 18 and older.
For more information about this study and to inquire about eligibility, please contact Dr. Ellin Berman at 212-639-7762.
Disease(s)
Leukemia
Leukemia: Chronic Myelocytic Leukemia
Locations
Related Diseases
