Azacitidine for Relapse Prevention in Transplant Eligible Patients with Acute Myeloid Leukemia Not Proceeding to Transplant

Inclusion Criteria

• Participants must have histologically or cytologically confirmed non-acute promyelocytic (APL) FLT3 negative AML and have completed induction and consolidation (0-4 cycles of consolidation – to be determined in the best interest of the patient at the discretion of the treating physician to allow for early discontinuation of consolidation due to toxicities and/or performance status), and must be in complete response (CR, complete response with partial hematological recovery [CRh], or complete response with incomplete count recovery [CRi]) at time of study enrollment
• For participants in CR1, AML disease phenotype must be one that is considered for Allogeneic hematopoietic cell transplant [alloHCT] in CR1 (intermediate or high risk by European Leukemia Network [ELN], MRD+ CR, slow clearance of MRD) or any AML phenotype (aside from FLT3+ and APL) in CR2 and beyond
• Medically eligible for alloHCT as defined by either: treating physician discretion, transplant physician discretion, or hematopoietic cell transplantation-comorbidity index (HCT-CI) index of 5 or less
• Age ≥ 18 years
• Enrollment must occur within 4 months of completion of therapy
• Inability to proceed to alloHCT transplant at time of study enrollment, as defined by timeline expected to be > 8 weeks, or indefinite
• Creatine clearance (by Cockroft-Gault formula) greater than or equal to 29 mL/min
• Total bilirubin less than or equal to 1.5 x upper limit of normal (except Gilbert’s syndrome, which may enroll if < 2 x patient’s baseline total bilirubin)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ to institutional 2 x upper limit of normal
• Eastern Cooperative Oncology Group (ECOG) 0,1,2,3
• Ability to take oral medications
• No history of malabsorption syndrome which, in the investigator’s opinion, may inhibit absorption of oral medications
• Women of childbearing potential must consent to effective contraception during study treatment and at least 6 months following the last dose. Women who are breast feeding are also excluded
• Male participants must consent to effective contraception during study and at least 3 months after last dose
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• FLT3 ITD or TKD mutation
• Uncontrolled central nervous system (CNS) involvement
• History of hypersensitivity or allergic reaction to azacitidine or its components
• Stem cell transplant within previous 3 months prior to initiation of study therapy
• Uncontrolled intercurrent illness or infection
• History of prior therapy with oral azacitidine
• Female participants who are pregnant or intend to donate eggs during the study or for 6 months after receiving their last dose of study drug
• Male participants who intend to donate sperm during the course of this study or for 3 months after last dose
• Other malignancy for which the participant is currently receiving therapy (except excisable skin cancer)
• Medical, psychological, or social condition that, in the opinion of the investigator, may increase the participant’s risk or limit the participant’s adherence with study requirements