Newly Diagnosed Acute Myeloid Leukemia Treatment Study
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.
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.