This clinical trial is focused on studying a type of blood cancer called Acute Myeloid Leukemia (AML), specifically in patients who are in their first remission after receiving standard chemotherapy. The study is investigating the use of two medications, Venetoclax and Azacitidine, as maintenance therapy. Maintenance therapy is a treatment given to help keep cancer from coming back after it has gone into remission. Venetoclax, also known by its code name ABT-199, is a medication that comes in the form of a film-coated tablet and is taken orally. Azacitidine is available in tablet form and can also be administered as a powder for suspension for injection, which means it can be given through a vein or under the skin.
The purpose of this study is to determine the best dose of Venetoclax in combination with Azacitidine for patients with AML who have achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after undergoing conventional induction and consolidation chemotherapy. The study will involve different parts, including dose confirmation and dose finding, to establish the recommended dose for these medications when used together as maintenance therapy. Participants will receive the study medications over a period of time, and their health will be monitored to assess the safety and effectiveness of the treatment.
Throughout the study, some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment. The study aims to provide valuable information on how well Venetoclax and Azacitidine work together in maintaining remission in patients with AML, potentially offering a new approach to managing this condition. The trial is expected to continue until 2025, with the goal of improving treatment options for patients with this type of leukemia.



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