A Phase 3 Open-label, Multicenter, Randomized Study of ASP2215 versus Salvage Chemotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with FLT3 Mutation

What we are studying

The purpose of the study is to see if a medicine called ASP2215 is both effective and safe as a treatment for AML patients with mutations in FLT3 gene identified by an investigational FLT3 Mutation Assay companion diagnostic (a specific way to test your blood or bone marrow, which is used to see have a mutation of the FLT3 gene), compared to salvage chemotherapy. Some AML patients have a mutation in the gene called FLT3. When patients have a FLT3 mutation, more of the FLT3 protein is on the leukemic cells, or the protein is more active. This may make the leukemic cells grow faster or live longer.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Diagnosis of primary AMO or AML secondary to MDS
  • Is refractory to or relapsed after first-line AMP therapy
  • Positive for FLT3

What is involved

  • ECOG Performance
  • Clinical lab tests
  • Bone Marrow Aspiration
  • PK
  • Patient reported outcomes
  • EQ-5D-5L


Parking will be validated for all study related visits.

Contact Information

Study Coordinator
Scarlett Hutchens
Principal Investigator
Timothy S. Pardee

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.