Ponatinib Hydrochloride as Second Line Therapy in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib Mesylate, Dasatinib, or Nilotinib
Trial Parameters
Brief Summary
This phase II trial studies how well ponatinib hydrochloride works as second line therapy in treating patients with chronic myeloid leukemia in chronic phase that has not responded to initial treatment (first line) with imatinib mesylate, dasatinib, or nilotinib or cannot tolerate imatinib mesylate, dasatinib, or nilotinib. Ponatinib hydrochloride may stop or control the growth of cancer cells by blocking a protein needed for cell growth.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of Philadelphia chromosome (Ph)-positive (by cytogenetics or fluorescent in situ hybridization \[FISH\]) or breakpoint cluster region (BCR)-ABL-positive (by polymerase chain reaction \[PCR\]) CML in chronic phase. * Participants should have demonstrated to have failure to therapy to one FDA-approved second-generation TKI (currently bosutinib, dasatinib, and nilotinib are approved as frontline therapy), defined as per European leukemiaNet (ELN)35 or National Comprehensive Cancer Network (NCCN) recommendations: * Less than complete hematologic response (CHR) at or beyond 3 months * No partial cytogenetic response at or beyond 3 months * BCR-ABL1 ≥ 10% at or beyond 3 months * BCR-ABL1 ≥ 1% at or beyond 6 months * Loss of CCyR or development of mutations or other clonal chromosomal abnormalities at any time during TKI treatment * Age \>18 years * ECOG performance of 0-2. * Adequate end organ function, defined as the following: total bilirubin ≤1.5x ULN (unle