A Phase III Study of ASP2215 versus Standard Salvage Chemotherapy for Recurrent or Persistent Acute Myelogenous Leukemia with an FLT3 Mutation

Full Title

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

Purpose

The standard treatment for patients with acute myelogenous leukemia (AML) that comes back despite prior treatment is "salvage" chemotherapy with conventional anticancer drugs. In this study, researchers want to see if the investigational drug ASP2215 is more effective than standard salvage chemotherapy in patients with recurrent or persistent AML that contains a mutation in a gene called FLT3.

The FLT3 mutation makes leukemia cells grow very quickly. ASP2215 may help kill AML cells by blocking the pathways that cells with this mutation use to grow and divide. Patients will be randomly assigned to receive ASP2215 or standard chemotherapy. ASP2215 is a pill that is taken orally (by mouth); the standard chemotherapy drugs are given either via subcutaneous injection (under the skin) or intravenously (by vein).

Eligibility

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

  • Patients must have AML that has come back or continued to grow despite initial therapy.
  • Patients must have an FLT3 mutation.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • 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

16-020

Phase

III

Investigator

Co-Investigators

Locations