Study of the BCL-2 Inhibitor Venetoclax in Combination With Standard Intensive Acute Myeloid Leukemia (AML) Induction/Consolidation Therapy With FLAG-IDA in Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia (AML)

Inclusion Criteria:

1. Diagnosis of AML by World Health Organization (WHO) criteria. Patients with high risk
myelodysplastic syndrome (MDS) as defined by the presence of >/= 10% blasts are also
eligible at the discretion of the Principal Investigator.

2. Patients >/= 18 to intensive chemotherapy by the treating physician will be eligible after discussion
with the PI.

3. Eastern Cooperative Oncology Group (ECOG) Performance Status of
4. Adequate renal function including creatinine clearance >/= 30 mL/min based on the
Cockcroft-Gault equation.

5. Adequate hepatic function including total bilirubin < 1.5x ULN unless increase is due
to Gilbert's disease or leukemic involvement, and AST and/or ALT < 3x ULN unless
considered due to leukemic involvement

6. Ability to understand and provide signed informed consent

7. Male subjects must agree to refrain from unprotected sex and sperm donation from
initial study drug administration until 90 days after the last dose of study drug.

8. Only patients who are relapsed, refractory, or intolerant of standard AML therapy will
be eligible for Part 1 (minimum of 1 prior line of AML-directed therapy)

Exclusion Criteria:

1. Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (FAB
class M3-AML)

2. Patients having received any prior BCL2 inhibitor therapy

3. Subject has known active central nervous system (CNS) involvement with AML.

4. Patients with New York Heart Association (NYHA) Class III or IV congestive heart
failure or LVEF < 40% by echocardiogram or multi-gated acquisition (MUGA) scan

5. Patients with a history of myocardial infarction within the last 6 months or unstable
/ uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular
arrhythmias

6. Patients with known infection with human immunodeficiency virus (HIV) or active
Hepatitis B or C

7. Patients with known dysphagia, short-gut syndrome, or other conditions that would
affect the ingestion or gastrointestinal absorption of drugs administered orally.

8. Subject has any other significant medical or psychiatric history that in the opinion
of the investigator would adversely affect participation in this study.

9. Subject has a white blood cell count > 25 x 10{9}/L. (Note: Hydroxyurea is permitted
to meet this criterion.)

10. Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy
test, or women of childbearing potential who are not willing to maintain adequate
contraception (a) Appropriate method(s) of contraception include oral or injectable
hormonal birth control, IUD, and double barrier methods (for example a condom in
combination with a spermicide).