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Newly Diagnosed Acute Myeloid Leukemia Treatment Study

Clinical Trial Title: 
A phase 3 study of quizartinib in combination with induction, consolidation, and maintenance chemotherapy, for subjects 18 to 75 years old with newly diagnosed FLT3-ITD (+) AML.
Clinical Trial Protocol ID: 
Clinical Trial Investigator Name: 
Melissa L. Larson, MD
Clinical Trial Protocol Description: 

Study for newly diagnosed AML patients with a FLT3-ITD mutation, which adds quizartinib/placebo to standard induction and consolidation maintenance therapy for subjects aged 18-75 and to collect additional data on treatment safety.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Are age 18-75 years old.
  • Have newly diagnosed, morphologically documented primary AML or AML secondary to MDS based on WHO 2008 classification.
  • Have the presence of FLT3-ITD activating mutation in bone marrow.
  • Are eligible to receive standard induction 7+3 chemothearpy.

You will be excluded from the study if any of the following criteria apply to you:

  • Have clinical evidence or history of CNS leukemia.
  • Have a history of other malignancies.
  • Have uncontrolled or significant cardiovascular disease.
  • Have a diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Blood Disorders and Hematologic Cancers
Contact Phone: 
(312) 942-1346
Contact Name: 
Kimberly Koetter, BS, RN, OCN, CCRC