What we are studying
Phase II studies are an early step in testing an investigational medication in humans. These studies look to see how many people complete the planned therapy and which of them has a response. It is the first step to determine if the experimental therapy can be tested in a larger trial.
The purpose of this study is to test whether the combination of an investigational drug called CPI-613 (“study drug”) given with two other chemotherapy drugs: cytarabine and mitoxantrone is effective in controlling your leukemia and how many patients complete all planned therapy. CPI-613 is thought to kill cancer cells by turning off their mitochondria. Mitochondria are used by cancer cells to produce energy and are the building blocks needed to make more cancer cells. By shutting off these mitochondria, CPI-613 deprives the cancer cells of energy and other supplies that they need to survive and grow in your body. We want to find out what effects, good and/or bad, CPI-613 has on you and your cancer when given along with cytarabine and mitoxantrone. We also want to see if CPI-613 when given alone as a maintenance therapy can prolong remission for those patients who respond to this treatment.
An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). CPI-613 is an investigational drug that has not been approved by the FDA for any type of tumor or cancer, and it is currently being studied for the treatment of cancer.
Parking will be validated for study-related visits.