A Study of Gilteritinib (ASP2215) in Patients with FLT3-Mutated Acute Myeloid Leukemia

Full Title

2215-CL-9100: A Multicenter, Open-label Treatment Protocol of Gilteritinib (ASP2215) in Patients with FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) with Minimal Residual Disease (MRD)

Purpose

Some patients with acute myeloid leukemia (AML) have a specific genetic mutation (abnormality) in their leukemia cells called the FLT3 mutation, which often makes leukemia cells grow very quickly. Gilteritinib (ASP2215) is a drug that may help kill leukemia cells by blocking the pathways that FLT3-positive cells use to grow and divide.

In this study, researchers are evaluating the safety and effectiveness of gilteritinib in patients with FLT3-mutated AML that has either not responded to treatment, has returned after treatment, or is in complete remission with minimal residual disease. Gilteritinib is taken orally (by mouth).

Eligibility

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

  • Patients must have FLT3-mutated AML that has either not responded to treatment, has returned after treatment, or is in complete remission with minimal residual disease.
  • This study is for patients age 18 and older.

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

Protocol

17-402

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators