A Phase 3 Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
The purpose of this protocol is to evaluate ponatinib as a potential treatment for patients who have been newly diagnosed with chronic myelogenous leukemia (CML). Ponatinib is FDA approved to treat patients with CML who have taken at least one prior therapy that did not work or stopped working. Ponatinib has been evaluated in two clinical trials with advanced CML and Philadelphia positive acute lymphocytic leukemia (Ph+ ALL) where other treatments were no longer working for participants’ conditions. Bases on the results observed in these studies, ponatinib may be effective in treating patients who have been newly diagnosed with CML.
This protocol will compare the effects of ponatinib with the effects of imatinib (an already FDA approved anti-cancer drug) on participants who are newly-diagnosed with CML to find out which works better.
Chronic Myelogenous Leukemia
1. 18 years old or older
2. Diagnosed with CML within the last 6 months
3. Ph+ CML
4. Has received no other therapy
18 - 99
Healthy Volunteers Needed
Duration of Participation
Up to 10 years
ARIAD Pharmaceuticals, Inc