In this study we want to find out the safest dose of the oral drug revumenib to give young children with KMT2A acute lymphoblastic leukemia that has come back or not responded to other treatment. We want to see if this treatment in combination with chemotherapy improves the health and survival of children with this type of cancer.
This study is divided into two parts. In the first, your child will receive both the oral drug revumenib and chemotherapy at the same time to treat their cancer. In the second part, they will receive only the oral drug revumenib. The study may last for up to 16 months, but the actual length will depend on how well the treatment works for their cancer. Some people may stop earlier based on their response to treatment. During the study, your child will have visits at Children's Hospital Colorado. Some visits will include hospital stays when the treatment is being administered. At study visits we will ask about their symptoms and perform physical exams. We will measure their height, weight, and vital signs. We will also take blood samples from a central line (a special tube placed in a large vein near the heart). We will ask them to give urine samples. We will take pictures and do tests to learn about the health of their heart. We will also take small samples of their bone marrow to see how well the treatment works. We will take samples of their spinal fluid to test for leukemia.
Your child may be able to join this study if they have acute KMT2A lymphoblastic leukemia and are between 1 month and 6 years old. They must have been diagnosed with leukemia before turning 2 years old. A doctor will need to check other details about your child’s cancer and health history to see if they can take part.
Protocol Number: 23-2394
More information available at ClinicalTrials.gov: NCT05761171
Principal Investigator