Dendritic Cell/AML Fusion Cell Vaccine Following Allogeneic Transplantation in AML Patients

Eligibility Criteria

• * Patients with AML who have undergone AML cell harvest and cryopreservation as per protocol 16-593 or companion protocol 18-232.
• * Patients must have had a minimum of 5x107 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.
• * Group B: Haplo-identical donor
• * Patients must be ≥ 18 years old
• * ECOG performance status ≤2 (Appendix A)
• * Participants must have normal organ and marrow function as defined below:
• * Total bilirubin ≤ 2.0 mg/dL (unless patient has Gilbert's disease)
• * AST(SGOT)/ALT(SGPT) ≤ 3 × 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 aGVHD
• * Must be on prednisone \<20mg or other steroid equivalent
• * Donor chimerism of bone marrow \>60%
• * Resolution of all transplant related grade III-IV toxicity as per CTC 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.
• * Assessments to be done between Day 45-75 post-transplant.
• * At least 2 doses of fusion vaccine were produced
• * No ongoing grade II-IV acute GVHD
• * Prednisone requirement of \< 20mg a day or steroid equivalent
• * Participants must have normal organ and marrow function as defined below:
• * Total bilirubin ≤ 2.0 mg/dL (unless patient has Gilbert's disease)
• * AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal
• * Creatinine ≤ 2.0 mg/dl
• * Absolute neutrophil count \> 1000
• * Platelet count \> 50,000
• * No uncontrolled acute infection
• * No CTCAE grade ≥ 3 non-hematologic toxicity
• * 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.
• * Participants must be in a complete remission
• * Assessments to be done within 3 days prior to initiation of therapy.
• * Participants must have normal organ and marrow function as defined below:
• * Total bilirubin ≤ 2.0 mg/dL (unless patient has Gilbert's disease)
• * AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal
• * Creatinine ≤ 2.0 mg/dl
• * Absolute neutrophil count \> 1000
• * Platelet count \> 50,000
• * Because of compromised cellular immunity, patients with a known history of HIV are excluded
• * Leukemia with active 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-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.
• * Autoimmune or inflammatory disorders requiring active treatment with systemic steroids or immunosuppressive therapy limited to the following:
• * GI Disorders: (including inflammatory bowel disease \[e.g., ulcerative colitis, Crohn's disease\]
• * Systemic lupus erythematosus
• * Wegener's syndrome \[granulomatosis with polyangiitis\]
• * Myasthenia gravis
• * Graves' disease
• * Rheumatoid arthritis
• * Hypophysitis
• * Uveitis