Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia

Inclusion criteria : * Able to provide informed consent. * Newly diagnosed acute myeloid leukemia (AML) to be treated with standard of care induction chemotherapy as per local policy. * Patients 55 to 70 years of age (inclusive). * Negative serum pregnancy test within 30 days prior to receiving the first dose of induction chemotherapy in female participants who are \<2 years postmenopausal or who are of childbearing potential and have agreed to begin or continue using an adequate method of contraception. Exclusion criteria: * Prior treatment with sargramostim or any leukocyte growth factor (LGF) product. * Prior myelodysplastic syndrome (MDS). * Known central nervous system (CNS) leukemic involvement diagnosed by cytologic findings in cerebrospinal fluid and/or by computed tomography (CT) or magnetic resonance imaging (MRI). * Out of range (\>2x normal) laboratory values. * Clinically important medical conditions unrelated to AML as determined by the Investigator. * Eastern Cooperative Oncology Group (ECOG) performance status \>2. * Bone marrow blasts ≥5% on marrow examination following induction or reinduction chemotherapy. * History of allergy to yeast products, recombinant human granulocyte/macrophage-colony-stimulating factor, or any component of sargramostim. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.