CADENCE: A trial exploring how safe and effective combining oral chemotherapy (Azacitidine) and an immunotherapy vaccine is in people with Acute Myeloid Leukemia (AML) who are in first complete remission (CR1).AMLM22/D4: The International AML Platform Consortium (IAPC) trial – is a randomised, 2-arm trial that will investigate the efficacy of oral Azacitidine combined with an allogeneic dendritic cell vaccine vididencel, compared with oral Azacitidine alone, in maintaining or inducing negativity for measurable residual disease (MRD) in AML patients in first complete remission (CR1) following intensive chemotherapy.

Exclusion

1. Presence of any exclusion criteria noted in the AMLM22 Master Protocol.
2. AML associated with inv(16), t(8;21), t(16;16) or molecular evidence of such translocations (ie. RUNX1::RUNX1T1, CBFB::MYH11)
3. There is an intent to undertake a stem cell transplant procedure in CR1.
4. Prior hypomethylating agents used in induction of AML. (Hypomethylating agents for a prior myelodysplastic syndrome (MDS) are permitted).
5. Unstable angina, significant cardiac arrhythmia, or New York Heart Association (NYHA) class 3 or 4 congestive heart failure;
6. Subject is HIV positive;
7. Evidence of other clinically significant, uncontrolled conditions(s) including, but not limited to
a) Uncontrolled and/or active systemic infection (viral, bacterial or fungal) (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment)
b) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIg) may participate.
8. Requirement for ongoing systemic immunosuppressive therapy equivalent to an average dose of greater than or equal to 10 mg of prednisone / day to avoid impairing the immune response to study therapy.
9. Active autoimmune disease, except for well controlled diabetes
10. Major surgical procedure (including open biopsy) within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment.
11. Known or suspected hypersensitivity to azacitidine and/or vididencel (or its excipients)
12. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study;
13. Pregnant or lactating women
14. Any condition that would impair absorption of the study medication (i.e. short gut, malabsorption syndrome).