A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients with Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses
The goal of this clinical research study is to study the effectiveness of 3 dose levels of ponatinib in treating CP-CML that is not responding to TKI treatment. The safety of these dose levels will also be studied. Ponatinib may cause a blood clot to form in an artery or in a vein. Depending on the location of the clot, this could cause a heart attack, a stroke, severe damage to other tissue, or death. A blood clot may occur within 2 weeks after you start taking the drug. About 41% (about 2 in 5) of patients taking the drug form an abnormal clot. Blood clots can occur in patients that do not have other known risk factors for forming clots. If you develop a blood clot, you will need to stop taking ponatinib. In some cases, emergency surgery could be needed to remove the clot and restore blood flow.
Disease Group: Leukemia
Treatment Agent: Ponatinib
Treatment Location: Both at MDACC & and Other Sites
Sponsor: ARIAD Pharmaceuticals, Inc.
IRB Review and Approval Date: 07/01/2015
Recruitment Status: Open
Projected Accrual: 276
Information and next steps
For general questions about clinical trials: