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

Inclusion 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.

OR

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.

Eligibility Prior to Initiating Vaccination (Groups A and B)

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

Pre-Treatment Criteria Prior to Decitabine (Group A Cohort 2)

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

Exclusion Criteria:

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