Late Stage Acute Myeloid Leukemia Study for Older Adults
This is an international, multicenter, open-label, randomized, phase 3 study comparing the efficacy and safety of AG-221 versus conventional care regimens in subjects 60 years or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation.
In order to participate you must meet the following criteria:
- Are 60 years of age or older.
- Have primary (de novo) or secondary (progression of MDS or MPN, or therapy –related) AML according to WHO classification.
- Have received second or third line/regimen of AML therapy.
- Have ECOG performance status of 0, 1, or 2.
- Have IDH2 gene mutations tested centrally in samples of bone marrow aspirate and peripheral blood, and confirmed positive in bone marrow aspirate and/or peripheral blood.
You will be excluded from the study if any of the following criteria apply to you:
- Are suspected or proven to have APL based on morphology, immunophenotype, molecular assay, or karyotype.
- Have AML secondary to CML.
- Have received a targeted agent against an IDH2 mutation.
- Have undergone HSCT within 60 days prior to the start of study treatment, or on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant GVHD.
- Have persistent, clinically significant non-hematologic toxicities from prior therapies.
- Are known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.
- Have uncontrolled hypertension.
This is a partial list of inclusion and exclusion criteria.