Clinical Trials | MM1OA-EA02, A Randomized Phase II Study of Venetoclax and HMA-based Therapies for the Treatment of Older and Unfit Adults with Newly Diagnosed FLT3-mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Treatment Trial

The University of Virginia Comprehensive Cancer Center seeks participants ages 60 or over with FLT3 Mutated Acute Myeloid Leukemia that have no prior therapy for AML with the exception of hydroxyurea and all-trans retinoic acid (ATRA), or leukapheresis. The purpose of this study is to compare the usual treatment of Azacitidine and Venetoclax to the combination treatment of Azacitidine, Venetoclax and Gilteritinib. In this study, you will either get Azacitidine through a vein in your arm or subcutaneously and Venetoclax by mouth for up to 2 years, or you will get Azacitidine through a vein in your arm or subcutaneously, Venetoclax and Gilteritinib as tablets that you take by mouth for up to 2 years. After you finish your study treatment, your doctor will continue to follow your condition for 10 years. Some of the most common side effects that the study doctors know about are: • Easy bruising/minor bleeding • Fatigue • Diarrhea • Fever/risk of infection There may be some risks that the study doctors do not yet know about. Azacitidine and Venetoclax are the most commonly used regimen for patients who are ineligible for intensive chemotherapy. It is not possible to know if combining the drugs in this study will decrease your cancer more than the usual approach. This study will help the study doctors learn things that will help people in the future. Additional information found here: Study Details | Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial) | ClinicalTrials.gov For questions, contact: [email protected]