Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia

Inclusion Criteria:

- ≥18 years and ≤75 years in age

- Patients with relapsed or refractory AML

- No more than one prior stem cell transplant

- Has not received the chemotherapy regimen to be used for induction on this trial

- Is considered medically eligible to receive the chemotherapy regimen to be used for
induction on this trial

Exclusion Criteria:

- Patients with acute promyelocytic leukemia, acute leukemia of ambiguous lineage
(biphenotypic leukemia), chronic myeloid leukemia with myeloid blast crisis, or
secondary refractory AML.

- Active signs or symptoms of CNS involvement by malignancy.

- Stem cell transplantation ≤4 months prior to dosing.

- Any immunotherapy or radiotherapy therapy within 28 days of dosing; any other
experimental therapy or chemotherapy within 14 days of dosing.

- Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing.

- Inadequate organ function.

- Abnormal liver function.

- Known active infection with hepatitis A, B, or C, or human immunodeficiency virus.

- Moderate kidney dysfunction (glomerular filtration rate <45 mL/min).

- Uncontrolled acute life-threatening bacterial, viral, or fungal infection.

- Clinically significant cardiovascular disease.

- Major surgery within 4 weeks of dosing.