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Most patients with chronic-phase chronic myeloid leukemia (CML) enjoy deep and durable remissions after treatment with the oral BCR-ABL tyrosine kinase inhibitors (TKIs) imatinib, nilotinib, or dasatinib. To address the unmet clinical need for patients who are refractory to these agents or who relapsed after treatment, investigators conducted an industry-supported, multicenter, phase I, dose-escalation study of ponatinib, a novel TKI that was rationally designed to overcome the resistant BCR-ABL T315I mutation. A total of 81 patients with CML, Philadelphia-chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), or other hematologic malignancies who relapsed or were refractory to standard therapy were eligible.
The most common nonhemato…