Clinical Trials | A measurable residual disease (MRD) focused, phase II study of venetoclax plus chemotherapy for newly diagnosed younger patients with intermediate risk Acute Myeloid Leukemia (AML): A Tier 1 myeloMATCH Clinical Trial

The University of Virginia Comprehensive Cancer Center seeks participants between ages 18 and 59 with a new diagnosis of acute myeloid leukemia (AML) that have not received prior therapy for AML except for hydroxyurea and leukapheresis to control blood counts. The purpose of this study is to compare the usual treatment used most frequently, which is cytarabine and daunorubicin alone, to two new approaches: adding venetoclax to cytarabine and daunorubicin, and adding venetoclax to another chemotherapy drug called azacitidine. In this study, you will either get cytarabine + daunorubicin + venetoclax for up to 11 days, or you will get azacitidine + venetoclax for up to two months, or you will get cytarabine + daunorubicin for up to 7 days. There is evidence that this study drug is effective in shrinking your type of cancer. It is not possible to know now if the study regimens will have a better rate of achieving elimination of your type of cancer compared to the usual approach. This study may help the study doctors learn things that may help other people in the future. The drugs used in this study may affect how different parts of your body work such as your liver, kidneys, heart, and blood. The study doctor will test your blood and let you know if changes occur that may affect your health. After you finish your study treatment, your doctor will continue to follow your condition for 5 years and watch you for side effects and keep track of your health. After study treatment, you may also be offered another clinical trial through the myeloMATCH study. You will continue to be followed on this study even if you continue onto another study. Follow-up includes a clinic visit 28 days after your treatment is complete, and clinic visits every 3 months for the first year, every 6 months for the second year, and annually for years 3-5 after you complete treatment. Additional information found here: https://www.clinicaltrials.gov/study/NCT05554393?titles=NCT05554393&rank=1 For questions, contact: [email protected]