Discontinuation of Hypomethylating Agent and Venetoclax in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Who Have Achieved Negative Measurable Residual Disease (MRD)
The purpose of this research study is to see if people whose Acute myeloid leukemia (AML) is being successfully treated with azacitidine or decitabine in combination with venetoclax can discontinue this chemotherapy for some period of time after a year of treatment without increasing the likelihood that their AML will return.
• Adults 18 years of age or older at the time of obtaining informed consent.
• Diagnosed with Acute Myeloid Leukemia (AML) (non-M3) as defined by 2016 World Health Organization (WHO)
• Eastern Cooperative Group (ECOG) performance status score ≤ 2
• Currently on frontline therapy with HMA (azacitidine or decitabine)/VEN and achieved Complete Remission (CR)/Complete Remission with incomplete marrow recovery (CRi) with MRD negativity defined as \< 0.1% by Multiparameter Flow Cytometry (MFC)
• Within 12 months of starting HMA (azacitidine or decitabine)/VEN
• Ineligible for or declined allogeneic hematopoietic cell transplantation (HCT)
• Ability to understand and the willingness to sign a written informed consent document
• Must agree to adhere to the study visit schedule and other protocol requirements
• Patients must be able to provide adequate Bone Marrow (BM) aspirate and biopsy specimens for histopathological and Measurable Residual Disease analysis during the screening procedure