A Phase 2 Study of Venetoclax in Combination With Low-dose HHT, G-CSF, and AZA as First-line Treatment for Newly Diagnosed Elderly AML Patients Unfit for Intensive Chemotherapy

Inclusion Criteria:

* Participant must have confirmation of Acute Myeloid Leukemia (AML) by World Health Organization (WHO) criteria, previously untreated and unfit for intensive chemotherapy
* Participant must be \>= 60 years of age.
* Participant must have a projected life expectancy of at least 12 weeks.
* Participant must have adequate renal function as demonstrated by a creatinine \>= 30 mL/min;determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula
* Participant must have adequate liver function as demonstrated by:

  1. aspartate aminotransferase (AST) \<= 3.0 x ULN\*
  2. alanine aminotransferase (ALT) \<= 3.0 x ULN\*
  3. bilirubin \<= 1.5 x ULN\* \* Unless considered to be due to leukemic organ involvement i. Subjects who are \< 75 years of age may have a bilirubin of \<= 3.0 x ULN

Exclusion Criteria:

* Participant has history of myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation
* Participant has acute promyelocytic leukemia
* Participant has known active central nervous system (CNS) involvement with AML
* Participant is known to be positive for hepatitis B or C infection
* Participant has received anticancer therapies including chemotherapy, radiotherapy or other investigational therapy, including targeted small molecule agents within 5 half-lives prior to first dose of study drug
* Participant has received biologic agents (e.g. monoclonal antibodies) for anti-neoplastic intent within 30 days prior to first dose of study drug
* Participant has received the following within 7 days prior to the first dose of the study drug:

  1. Steroid therapy for anti-neoplastic intent;
  2. Strong and Moderate CYP3A inhibitors (see Appendix A for examples)
  3. Strong and Moderate CYP3A inducers (see Appendix A for examples)
* Participant exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy
* Participant has a serious cardiovascular, pulmonary or renal disability
* Participant has a history of other malignancies within 2 years prior to study entry, with the exception of:

  1. Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
  2. Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
  3. Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent; requires discussion with TA MD.