Gilteritinib on Newly Diagnosed AML/ FLT3 Mutation

September 18, 2018

A Phase 3 Multicenter, Open-label, Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia with FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy

  • Clinical Trial Information

    Trial Contact: Walton, Sherri; Manchola-Orozco, Carolina

    Trial Phone: 321.841.1907 ; 321.841.7293

  • IRB No: 18.019.02

    Protocol Abbrev: 2215-CL-0201

    Principal Investigator: Jose E. Sarriera, MD

    Phase: Drug: Phase II;Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: 2215-CL-0201

    Treatment: Gilteritinib and Azacitidine (alone and combined)

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT02752035

  • Objective

    The primary objective is to:
    Determine the efficacy superiority of ASP2215 and/or ASP2215 plus azacitidine versus azacitidine as measured by overall survival (OS).
    The key secondary objective is to:
    Determine the efficacy superiority of ASP2215 and/or ASP2215 plus azacitidine versus azacitidine as measured by event-free survival (EFS).

  • Key Eligibility

    Newly diagnosed, FLT3 mutated AML subjects not eligible for intensive induction