A Phase 3 Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women who have been recently diagnosed with chronic myeloid leukemia (CML). The purpose of the study is to evaluate the experimental drug ponatinib as a potential treatment for people with newly diagnosed CML.

Previous research suggests that ponatinib stops cancer cells from growing by affecting different kinds of proteins in cancer cells. In particular, laboratory studies suggest that ponatinib may be effective in stopping a protein called breakpoint cluster region-abelson (BCR-ABL), which is important in CML. Earlier clinical trials in people with advanced CML and Philadelphia positive acute lymphocytic leukemia (Ph+ALL) indicate that ponatinib may be effective in treating people newly diagnosed with CML.

 This study will compare the effects of ponatinib to a drug called imatinib. Imatinib is FDA-approved to treat a variety of cancers.  Study participants will be randomly assigned to receive either ponatinib or imatinib. There is no placebo.

Participants will take either ponatinib or imatinib by mouth once daily. The length of time on study medications depends on how well a participant’s cancer responds to treatment. 

Disease Status and/or Stage

Newly Diagnosed Chronic Myeloid Leukemia



Key Eligibility

  • Men and women age 18 and older
  • Diagnosed with Chronic Myeloid Leukemia (CML) within past 6 months
  • No prior systemic anticancer therapy or radiation therapy for CML
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Gail Roboz, MD


Protocol ID


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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