AZA + Venetoclax as Maintenance Therapy in Patients With AML in Remission

Prior treatment

• Diagnosis of AML associated t(15;17) or APL variant. Patients with t(9;22) are also ineligible unless they are unable or unwilling to receive therapy with a tyrosine kinase inhibitor.

Other illness

• Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with active CNS (central nervous system) disease.
• Patients with documented hypersensitivity to any components of the study program.
• Patients with history of extramedullary AML, except for CNS involvement that is currently controlled, will not be eligible for enrollment.

Other

• Diagnosis of acute promyelocytic leukemia (APL), AML - M3 by FAB classification based on morphology, immunophenotype, molecular, or cytogenetic s studies.
• Females who are pregnant or lactating or intending to become pregnant during the study.
• Patient should be removed from current trial if they wish to participate and get treatment on another trial.

• Patients aged >/= 18 years AML who have achieved their FIRST CR or CRi and are not immediately candidates for allogeneic stem cell transplant.
• Patients who have received intensive therapy (defined as receiving standard or higher dose cytarabine-based therapy) to achieve remission (CR/CRi) should have received remission induction therapy and at least 1 consolidation cycle. These patients are eligible as long as they are not greater than 2 months from their last consolidation therapy and will be enrolled in COHORT 1.
• Patients who have received lower intensity therapy (defined as receiving low-dose cytarabine (LDAC) or hypomethylating agent (HMA)-based therapy) to achieve remission should have received at least 2 cycles of lower intensity therapy between the time they have achieved CR/CRi and enrollment on this protocol. They will be treated on COHORT 2.
• For either subgroup (lower or higher intensity), patients who have measurable residual disease may be enrolled on their respective cohort at any time without maximum 'time from consolidation' requirement.
• ECOG performance status of < or = 3
• Adequate organ function as follows:
  • Serum total bilirubin < or = to 1.5 X the Upper Limit of Normal (ULN)
  • Serum creatinine < or = to 2.5 x ULN
• Adequate BM reserve:
  • Absolute neutrophil count (ANC) > 0.5 x k/uL
  • Platelet count > or = 30 x k/uL
• For females of childbearing age, they may participate if they:
  • Have a negative serum or urine pregnancy test within 10 to 14 days of enrolling
  • Agree to either abstinence or 2 effective contraceptive methods (such as barrier methods or hormonal contraception) throughout the treatment period and up to 30 days after discontinuing treatment.
• For male patients with a female partner of childbearing age, they may participate if they agree to either abstinence or 2 effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment.
• Ability to understand and sign informed consent.