A Phase II Study of Crenolanib plus Chemotherapy in Patients with Newly Diagnosed Acute Myeloid Leukemia with FLT3-Activating Mutations

Full Title

A Safety and Tolerability Trial of Crenolanib and Chemotherapy with Cytarabine and Anthracyclines in Patients with Newly Diagnosed Acute Myeloid Leukemia with FLT3 Activating Mutations

Purpose

FLT3 is a protein that, when altered, can drive the growth of acute myeloid leukemia (AML). Crenolanib is an investigational drug that inhibits both mutated and normal FLT3. In this study, researchers are assessing the safety of crenolanib when given with combination chemotherapy in patients newly diagnosed with AML.

Patients will receive cytarabine with either daunorubicin or idarubicin, followed by crenolanib. Crenolanib is taken orally (by mouth), while the other chemotherapy drugs are given 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 not yet been treated.
  • Patients AML must contain FLT3-activating mutations.
  • 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 about this study and to inquire about eligibility, please contact Dr. Martin Tallman at 212-639-3842.

Protocol

15-084

Phase

II

Investigator

Co-Investigators

Locations