Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)

Exclusion Criteria

• •Received prior TKI treatment within 7 days prior to receiving the first dose of ponatinib, or have not recovered from adverse events (except alopecia) due to agents previously administered.
• •Received other therapies as follows:
• •1. For CML chronic phase (CP) and accelerated phase (AP) participants, received hydroxyurea or anagrelide within 24 hours prior to receiving the first dose of ponatinib; interferon, cytarabine, or immunotherapy within 14 days prior to first dose of ponatinib; or any other cytotoxic chemotherapy, radiotherapy, or investigational therapy within 28 days prior to receiving the first dose of ponatinib.
• •2. For CML blast phase (BP) participants, received chemotherapy within 14 days prior to the first dose of ponatinib.
• •3. For Ph+ ALL participants, received corticosteroids within 24 hours before the first dose of ponatinib; or vincristine within 7 days prior to the first dose of ponatinib; or received other chemotherapy within 14 days prior to the first dose of ponatinib.
• •Underwent stem cell transplant \<60 days prior to receiving first dose of ponatinib
• •Evidence of on-going graft versus-host disease (GVHD), or GVHD requiring immunosuppressive therapy
• •Taking medications that are known to be associated with Torsades de Pointes
• •Require concurrent treatment with immunosuppressive agents (other than corticosteroids prescribed for a short course of therapy)
• •Previously treated with ponatinib
• •CML CP participants are excluded if they are in Complete cytogenetic response (CCyR)
• •Participants with CML AP, CML BP, or Ph+ ALL are excluded if they are in Major Hematologic Response (MaHR).
• •Have active Central Nervous System (CNS) disease
• •Have significant or active cardiovascular disease
• •Have a significant bleeding disorder unrelated to CML or Ph+ALL
• •Have a history of pancreatitis or alcohol abuse
• •Have uncontrolled hypertriglyceridemia (triglycerides \>450 mg/dL)
• •Have malabsorption syndrome or other gastrointestinal illness that could affect absorption of ponatinib
• •Diagnosed with another primary malignancy in the past 3 years
• •Pregnant or lactating
• •Underwent major surgery within 14 days prior to first dose of ponatinib
• •Have ongoing or active infection
• •Suffer from any other condition or illness that would compromise safety or interfere with evaluation of the drug