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

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.