Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive Clinical Trial
Official title:
Ponatinib as Second Line Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib, 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.
Primary Objectives: - To estimate the proportion of participants with tyrosine kinase inhibitor (TKI)-resistant, chronic phase CML (CP-CML) attaining major cytogenetic response (MCyR) at 6 months of treatment with second line ponatinib therapy. - To estimate the time to toxicity related to ponatinib for patients with TKI-resistant CP-CML. Secondary Objectives: - To estimate the proportion of participants achieving a MCyR, complete cytogenetic response (CCyR), major molecular response (MMR) and complete molecular response (CMR) at 3, 6, 12, 18 and 24 months of treatment with ponatinib after one second generation TKI failure (by resistance). - To estimate the time to CCyR, MMR, MCyR and CMR for participants treated with ponatinib as second line therapy for CP-CML - To evaluate the durations of hematologic, cytogenetic and molecular response to ponatinib after one second generation TKI failure. - To define the time to progression and overall survival for participants with CML in chronic phase treated with ponatinib after one second generation TKI failure. - To evaluate the toxicity profile of ponatinib in participants with CML in chronic phase after one second generation TKI failure. - To evaluate the probability of developing ABL mutations for participants with CML in chronic phase treated with ponatinib after one second generation TKI failure. - To analyze differences in response rates and in prognosis according to pre-treatment mutations and patient characteristics. - To investigate mechanisms of resistance in patients who develop resistance to ponatinib used as second line therapy for CP-CML. - To evaluate symptom burden in participants with CP-CML receiving ponatinib. Exploratory Objectives: • To investigate the presence of miRNA that may be predictive of outcome ;
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