A Phase II/III Study of ASP2215 (Gilteritinib) and Azacitidine Individually and Together in Patients with Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutations Who Cannot Have Intensive Induction Therapy

Full Title

2215-CL-0201: A Phase 2/3 Multicenter, Open-label, 3-arm, 2-stage 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

Purpose

Prior studies in patients with acute myeloid leukemia (AML) who have FLT3 mutations suggest that the investigational drug ASP2215 (gilteritinib) may help reduce the number of FLT3-positive AML cells in the bone marrow. Azacitidine is a chemotherapy drug already used to treat patients newly diagnosed with AML who are unable to tolerate the standard intensive induction therapy for this disease.

In this study, researchers are evaluating the safety and effectiveness of combining azacitidine with ASP2215 in patients with newly diagnosed AML who have FLT3 genetic mutations and are not candidates for intensive induction chemotherapy. Patients will be randomly assigned to receive ASP2215 alone, ASP2215 plus azacitidine, or azacitidine alone. ASP2215 is taken orally (by mouth). Azacitidine is given intravenously (by vein) or through a subcutaneous injection (under the skin).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be newly diagnosed with AML and have an FLT3 mutation.
  • Patients may not be considered eligible for intensive induction chemotherapy due to advanced age (75 or older) or other health conditions.
  • Patients may not have received prior chemotherapy for AML.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Ellin Berman at 212-639-7762.

Protocol

18-033

Phase

II/III

Investigator

Co-Investigators