This trial is evaluating the effectiveness of KRT-232 for the treatment of acute myeloid leukemia (AML). The main outcomes are the number of patients who achieve complete remission, and how many patients stop treatment due to side effects. This study is being conducted in Columbus, Ohio, United States.
The details
AML is a cancer of the blood and bone marrow. It is the most common type of leukemia in adults. Research suggests that a protein called MDM2 contributes to the development of AML. KRT-232 is a drug that inhibits MDM2.
This study will evaluate KRT-232 as a treatment for AML. The primary outcomes are how many patients achieve complete remission and how many patients have side effects.
Who are they looking for?
This study is looking for 160 patients with AML. Patients must have normal liver and kidney function. Women who are pregnant or breastfeeding cannot participate in this study. This study will have two parts. To participate in Part A, patients must have AML that has come back (relapsed) or stopped responding to treatment (refractory). To participate in Part B, patients must have AML that has a JAK2 mutation or that developed from another blood cancer.
Patients with AML that has a p53 mutation cannot participate. Patients previously treated with an MDM2 inhibitor cannot participate. Patients must not have received a stem cell transplant or have active graft-versus-host disease. Patients with AML present in the brain or spinal cord cannot participate. Patients who have had major surgery within the past month cannot participate.
How will it work
This study will have two parts. During Part A, side effects from treatment will be measured. During Part B, the number of patients achieving complete remission will be measured. Patients will receive either low-dose cytarabine (Cytosar-U) or decitabine (Dacogen) along with KRT-232, in one of three dosing schedules.
The primary outcomes will be how many patients achieve complete remission and how many patients have side effects. Safety and effectiveness will be evaluated for 1 cycle of treatment (28 days).
