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