10212 A Phase 1b/2 Study of Pinometostat in Combination with Standard Induction Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia with MLL Rearrangement
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this study is to test the safety of a drug called pinometostat, when given in combination with standard chemotherapy for acute myeloid leukemia, at different doses.
You may be eligible if you have Acute Myeloid Leukemia (AML) and your cancer has a change in the gene called MLL (lysine methyltransferase 2A).
This study has a screening step. The purpose of this step is to test your tumor to find out if it has a specific gene change. If it does and you meet all the study requirements, then we can assign you to treatment based on these changes. If we find that your blood does not have the genetic changes that are needed for this study, then your doctor will discuss other options for your care. In the first part of this study (called the “safety run-in phase”), different people will receive different doses of the study drug pinometostat, in combination with a standard of care treatment for acute myeloid leukemia. In the later part of this study (called the “dose expansion phase”), everyone will receive the same dose of pinometostat.Treatment schedule: You will get pinometostat through a vein in your arm continuously for 35 days. Beginning on the 8th day, you will receive daunorubicin through a vein in your arm daily for 3 days. Also beginning on the 8th day, you will receive cytarabine through a vein in your arm continuously for 7 days.In the dose expansion phase of this study, all participants will receive the same doses of pinometostat as either group 1, or group 2, depending on which was safer. Patients in this group will also receive the same standard of care combination of daunorubicin and cytarabine described above as in the safety run-in phase. There will be up to 25 people in this group.You will not be able to get additional doses of the drug. This drug is not approved by the FDA for treatment of your disease.
08/11/2020 05:02 AM