Dendritic Cell/AML Fusion Cell Vaccine in Treating Patients with Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant

Inclusion Criteria

• Patients with AML who have undergone AML cell harvest and cryopreservation as per protocol 16-593 (NCI-2017-01191) or companion protocol 18-232
• Patients must have had a minimum of 1 x 10^7 cells cryopreserved
• Patients must be day 25-45 following allogeneic transplantation from either: * Group A: HLA 8/8 or 7/8 matched related donor or HLA 8/8 matched unrelated donor, as determined by antigen or allele level typing at HLA A,B,C, and HLA DRB1. OR * Group B: Haplo-identical donor ** Note: Participants who do not meet eligibility by day 45 post-transplant may be evaluated for eligibility to be enrolled to the study up to day 90 post-transplant, with approval from the overall principal investigator
• Patients must be >= 18 years old
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Total bilirubin =< 2.0 mg/dL (unless patient has Gilbert’s disease)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal
• Creatinine =< 2.0 mg/dl
• Absolute neutrophil count > 1000
• Platelet count > 50,000
• The effects of DC/AML fusion cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• No evidence of ongoing grade 2 or higher acute (a)GVHD
• Must be on prednisone < 20 mg or other systemic steroid equivalent
• Donor chimerism of bone marrow >= 60%
• Resolution of all transplant related grade 3-4 toxicity as per Common Terminology Criteria for Adverse Events (CTCAE) criteria 4.0
• Complete remission defined by absence of circulating blasts and less than 5% blasts in the bone marrow
• Ability to understand and the willingness to sign a written informed consent document
• Prior to Initiating Vaccination: At least 2 doses of fusion vaccine were produced
• Prior to Initiating Vaccination: No ongoing grade II-IV acute GVHD
• Prior to Initiating Vaccination: Prednisone requirement of < 20 mg a day or other systemic steroid equivalent
• Prior to Initiating Vaccination: Total bilirubin =< 2.0 mg/dL (unless patient has Gilbert’s disease)
• Prior to Initiating Vaccination: AST(SGOT)/ALT(SGPT) =< 3 x institutional upper limit of normal
• Prior to Initiating Vaccination: Creatinine =< 2.0 mg/dl
• Prior to Initiating Vaccination: Absolute neutrophil count > 1000
• Prior to Initiating Vaccination: Platelet count > 50,000
• Prior to Initiating Vaccination: No uncontrolled acute infection
• Prior to Initiating Vaccination: No CTCAE grade >= 3 non-hematologic toxicity
• Prior to Initiating Vaccination: No serious intercurrent illness such as active acute infection, or significant cardiac disease characterized by clinically significant arrhythmia, active ischemic coronary disease or symptomatic congestive heart failure
• Prior to Initiating Vaccination: Participants must be in a complete remission
• Prior to Initiating Vaccination: Calcineurin inhibitor will be tapered
• Prior to Initiating Booster Vaccine: 30-60 days following withdrawal of immune suppression
• Prior to Initiating Booster Vaccine: No evidence of chronic GVHD
• Prior to Initiating Booster Vaccine: No ongoing need for systemic steroids, with the exception of physiologic replacement doses for adrenal insufficiency
• Prior to Initiating Booster Vaccine: Total bilirubin =< 2.0 mg/dL (unless patient has Gilbert’s disease)
• Prior to Initiating Booster Vaccine: AST(SGOT)/ALT(SGPT) =< 3 x institutional upper limit of normal
• Prior to Initiating Booster Vaccine: Absolute neutrophil count > 1000
• Prior to Initiating Booster Vaccine: Platelet count > 50,000 unsupported by transfusion
• Prior to Initiating Booster Vaccine: No uncontrolled acute infection
• Prior to Initiating Booster Vaccine: No CTCAE grade >= 3 non-hematologic toxicity

Exclusion Criteria

• Because of compromised cellular immunity, patients with a known history of human immunodeficiency virus (HIV) are excluded
• Leukemia with active central nervous system (CNS) involvement
• Patients must not be pregnant. All premenopausal patients will undergo pregnancy testing. Men will agree to not father a child while on protocol treatment. Men and women will practice effective birth control while receiving protocol treatment
• Participants may not be receiving any other non-Food and Drug Administration (FDA) approved study agents at the start of vaccination
• Uncontrolled intercurrent illness including uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements
• Patients with active systemic autoimmune disease requiring ongoing systemic therapy are excluded. The following is an exception to this criterion: subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement. Patients with paraneoplastic auto-immune manifestations related to AML are permitted