Clinical Trials | Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia

The University of Virginia seeks participants ages 18 and over with relapsed or refractory acute myeloid leukemia (AML) with documented NPM1-m or KMT2A-r. The purpose of this study is to learn how ziftomenib works in combination with standard of care treatments (SOC). This will help determine the safety a well-tolerated dose of ziftomenib in combination with SOC. In this study, you will undergo a screening period that can last up to 28 days. During the screening period, the doctor will run various tests to make sure you are eligible for the study. If you are eligible to participate, you will enter into NPM1-m AML cohort or KMT2A-r AML cohort and start receiving treatment. Each cohort will participate in a Dose Escalation section which helps determine well-tolerated dose of ziftomenib in combination of SOC treatment. Once completed, you will participate in the Dose-Validation Expansion section which further study the effects of ziftomenib in combination with SOC treatment. The dose that was discover in the dose escalation section will be used in the Dose-Validation Expansion section. Your participation in the study may be approximately 2 years but will also depend on how you tolerate the study drugs, how your cancer responds to the treatment, and your overall condition. Not all patients will stay in the study for the same amount of time. Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance. Additional information can be found here: https://clinicaltrials.gov/study/ NCT06001788 [email protected] The (department, division name) seeks (insert as applies: adults/men/women/adolescents/children) ages (insert) with (insert condition) for a research study. The purpose of the study is (insert purpose of study - eg.to test the effectiveness of an investigational medicine; or to find out how stress effects blood pressure.) (Optional)You may be eligible for this study if: (insert brief eligibility criteria 3 or 4 top criteria and in lay language. Do not copy eligibility criteria from the protocol) Study involves (insert procedures-examples: taking an experimental medicine/placebo, blood draws, x rays, overnight stays,) (Insert x number of visits every x (weeks, months,) each visit lasting x amount of time or give range). Insert one of the following: Study-related (insert exams, tests and experimental medication) provided at no cost. or Participant’s insurance company will be billed for medication, tests and procedures