A Phase 3, Randomized, Open-label, Multicenter Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Intensity Chemotherapy, in Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Ponatinib, Prednisone, Vincristine
The goal of this clinical research study is to compare ponatinib and imatinib in combination with chemotherapy when given to patients with Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Imatinib is the current standard of care given to patients with Ph+ ALL. However, there is a high percentage of patients who relapse (the disease comes back), especially in patients who have a specific genetic mutation (change) called a T315I mutation. Patients with this mutation are resistant to imatinib (which means the drug may not work as well and cause the disease to come back). However, ponatinib is able to overcome the resistance caused by this mutation. As such, patients may benefit from this therapy. This means there may be a lower chance of the disease coming back. As part of this study, researchers will compare the effectiveness of ponatinib against imatinib to learn which drug may better help patients with Ph+ ALL. It is important to note that 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. If a blood clot forms, you will receive standard treatment.
Disease Group: Malignant neoplasms stated as primary lymphoid haematopoietic
Treatment Agent: Ponatinib, Prednisone, Vincristine
Treatment Location: Both at MD Anderson & Other Sites
Sponsor: Millennium Pharmaceuticals, Inc.
IRB Review and Approval Date: 11/08/2018
Recruitment Status: Open
Projected Accrual: 230-320
Information and next steps
Malignant neoplasms stated as primary lymphoid haematopoietic
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