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

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.

Trial Details

NCT ID
NCT01746836
Phase
PHASE2
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Laboratory Biomarker Analysis
  • Ponatinib Hydrochloride
  • Quality-of-Life Assessment
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Diagnosis of Philadelphia chromosome (Ph)-positive (by cytogenetics or fluorescent in situ hybridization \[FISH\]) or breakpoint cluster region (BC…
  • Participants should have demonstrated to have failure to therapy to one FDA-approved second-generation TKI (currently bosutinib, dasatinib, and nil…
  • Less than complete hematologic response (CHR) at or beyond 3 months
  • No partial cytogenetic response at or beyond 3 months

For full eligibility, visit ClinicalTrials.gov.

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