Clinical Trial Details

Short Title
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

Description

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.

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
Department or Field of Study
Keywords
cancer ; carter ; chronic myelogenous leukemia (CML) ; imatinib ; IRB#201211504 ; leukemia ; phase 3 ; phase III ; ponatinib ;

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