Description
This study enrolls patients that have been diagnosed with acute leukemia associated with a KMT2A (MLL) gene rearrangement (referred to as KMT2Arearranged, or KMT2A-R). The KMT2A-R leukemia has come back after treatment (relapsed) or is not responding to treatment (it is refractory). This study involves taking a study drug called SNDX-5613. The study is divided into two phases: one in which the study drug is given in combination with chemotherapy and a phase where the study drug is given alone. The purpose of the study is to test the safety of the study drug with chemotherapy, and how well the treatment regimen works for infants and young children with relapsed or refractory KMT2A-R leukemia.
What to expect
As a participant in the research, you will:â¢Depending on which phase you enroll into, you will either receive a study drug called SNDX-5613 OR receive a study drug called SNDX-5613 in addition to chemotherapy you would receive as part of your regular cancer careâ¢Complete frequent clinic visits at CHOPâ¢Have a bone marrow evaluationâ¢Have frequent blood testsâ¢Have extra or leftover bone marrow collected if you have bone marrow samples collected as part of your regular cancer careâ¢Complete medication diariesâ¢Have periodic electrocardiograms (ECGs) and echocardiograms (ECHOs) as part of your regular cancer care
â¢Have periodic imaging performed as part of your regular cancer care to evaluate your response to treatment
