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Late Stage Acute Myeloid Leukemia Study for Older Adults

Clinical Trial Title: 
A phase 3, multicenter, open-label, randomized study comparing the efficacy and safety of AG-221 (CC-90007) versus conventional care regimens in older subjects with late stage AML harboring an isocitrate dehydrogenase 2 mutation.
Clinical Trial Protocol ID: 
Clinical Trial Investigator Name: 
Melissa L. Larson, MD
Clinical Trial Protocol Description: 

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.

Clinical Trial Eligibility Criteria: 

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.

Clinical Trial Area: 
Blood Disorders and Hematologic Cancers
Contact Phone: 
(312) 942-1346
Contact Name: 
Kimberly Koetter, BS, RN, OCN, CCRC