A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects with FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Study Status

Open to Enrollment

Study Description

This is a study of an experimental drug called Quizartinib (also called AC220 or ASP2689). The purpose of the study is to compare the safety and effectiveness of two doses of Quizartinib in people with relapsed or refractory acute myeloid leukemia (AML).

Some people with AML have a gene mutation called FLT3-ITD. Quizartinib is designed to block the FLT3 receptor on leukemia cells. This may slow or stop leukemia cell division and may lead to leukemia cell death.  The drug may also work against other receptors that are involved in leukemia cell division and growth.

Participants will be randomly assigned to one of two doses of Quizartinib (30 mg or 60 mg).

Quizartinib is a liquid taken by mouth. Study participants will take daily doses of the drug. 

Disease Status and/or Stage

Relapsed or Refractory Acute Myeloid Leukemia (AML); AC220; ASP2689; blood cancer treatment; Ellen Ritchie; Gail Roboz; Weill Cornell Leukemia: New York Presbyterian Hospital


Astellas Pharma

Key Eligibility

  • Age 18 or older
  • Relapsed or refractory AML
  • FLT3-ITD positive (determined at screening)
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Ellen Ritchie, MD


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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