Chemo Combo: This phase I trial is evaluating ABT-199 (an oral drug) in combination with two chemotherapy drugs (azacitidine or decitabine) for the treatment of newly diagnosed Acute Myelogenous LeukaemiaA Phase 1b Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine in Treatment Naive Subjects With Acute Myelogenous Leukemia Who Are Greater Than or Equal to 65 Years of Age and Who Are Not Eligible for Standard Induction Therapy

Exclusion

• Subject has received treatment with the following hypomethylating agent and/or chemo therapeutic agent for for an antecedent hematologic disorder (AHD) (Subjects may have been treated with other agents for AHD i.e., Myelodysplastic syndrome [MDS])
• Subject has history of Myeloproliferative Neoplasm (MPN).
• Subject has favorable risk cytogenetics as categorized by the National Comprehensive Cancer Network Guidelines Version 2, 2014 for AML.
• Subject has t(8;21), inv(16), t(16;16) or t(15;17) karyotype abnormalities.
• Subject has acute promyelocytic leukemia.
• Subject has known active central nervous system involvement with AML.
• Subject has received a strong and/or moderate CYP3A inducer within 7 days prior to the initiation of study treatment.

• Subject has a history of other malignancies prior to study entry, with the exception of:

  • Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
  • Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
  • Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
• Subject has a white blood cell count > 25 × 10^9/L. Note: Hydroxyurea is permitted to meet this criterion.