Clinical Trial Details
Enter Short Title Official Title:
A Phase 3 Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Start Date April 2, 2013
End Date October 17, 2013
| Gender Preference |
|None|| Age Group |
|18 - 99 years|
| Principal Investigator |
|Thomas Carter, MD, PhD|
| Contact Info |
Karen Parrott, 319-353-6347
|Department or Field of Study|
Participants in this study have recently been diagnosed with a type of leukemia (blood cancer) called chronic myelogenous leukemia (CML).
The purpose of this study is to evaluate ponatinib as a potential treatment for patients who have been newly diagnosed with CML. Ponatinib is an experimental anti-cancer drug.
This study will compare the effects of ponatinib to another drug called imatinib. Imatinib is approved by the United States Food and Drug Administration (FDA) for treating a variety of human cancers including newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in the chronic phase.
This study will enroll approximately 530 participants (subjects) in about 175 centers worldwide.
|cancer ; carter ; chronic myelogenous leukemia (CML) ; imatinib ; IRB#201211504 ; leukemia ; phase 3 ; phase III ; ponatinib ; |