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Study Design and Objectives

Eligibility. CML in any phase (CP, AP, or BP of either myeloid or lymphoid phenotype) or Ph ALLPreviously treated with and resistant or intolerant to dasatinib or nilotinibORDeveloped the T315I mutation after treatment with any TKINoteCriteria strictly defined in the protocol for each CML phas

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Study Design and Objectives

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    2. Study Design and Objectives Multicenter, multinational, single arm, phase 2 open-label trial Primary Objective To determine the efficacy of ponatinib in patients with CML in CP, AP, BP or with Ph+ ALL who are either: Resistant or intolerant to either dasitinib or nilotinib, OR Have the T315I mutation Secondary Objectives To further characterize the anti-leukemia activity of ponatinib as evidenced by clinical responses, molecular responses, and clinical outcomes To characterize the molecular genetic status of patients To examine the safety of ponatinib in these patients

    3. Eligibility CML in any phase (CP, AP, or BP of either myeloid or lymphoid phenotype) or Ph+ ALL Previously treated with and resistant or intolerant to dasatinib or nilotinib OR Developed the T315I mutation after treatment with any TKI Note Criteria strictly defined in the protocol for each CML phase Cannot have CCyR in CP or MaHR in AP/BP/ALL Resistant (failure to respond) or intolerant (loss of response)

    4. Other Inclusion Criteria Informed consent =18 years old ECOG =2 =3 months life expectancy Adequate hepatic, renal and pancreatic function Normal QTcF interval on screening ECG Negative pregnancy test Use an effective form of contraception Ability to comply with study procedures

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