A Phase 3 Study of Quizartinib Given With Induction and Consolidation Chemotherapy and as Maintenance Therapy to Treat Newly Diagnosed FLT3-ITD-Negative Acute Myeloid Leukemia

Full Title

A Phase 3, Double-Blind, Randomized, Placebo-controlled Trial of Quizartinib Administered in Combination with Induction and Consolidation Chemotherapy and Administered as Maintenance Therapy in Adult Patients with Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia (QuANTUM-Wild) (WCG)

Purpose

Researchers want to see how well quizartinib works to treat acute myeloid leukemia (AML). The people in this study have AML that does not have a genetic change called FLT3-ITD. In addition, they have not yet had any treatment for AML.

The investigators will see how quizartinib works when taken with standard chemotherapy and alone to prevent the disease from returning. If you take part in this study, you will be randomly assigned to one of these treatment groups:

• Quizartinib for the whole study, first with chemotherapy and then alone as maintenance therapy.
• Placebo (inactive drug) for the whole study, first with chemotherapy and then alone as maintenance therapy.
• Quizartinib with chemotherapy, followed by placebo alone as maintenance therapy.

Who Can Join

To join this study, there are a few conditions. You must:

• Have AML that has not yet been treated and is negative for FLT3-ITD.
• Be able to walk and do routine activities for more than half the time you are awake.
• Be age 18 or older.

Contact

For more information about this study or to see if you can join, please call Dr. James Yoon’s office at 646-608-3768.