A Phase I Clinical Trial of Dendritic Cell/AML Fusion Cell Vaccine Alone and in Conjunction With Decitabine Following Allogeneic Transplantation in AML Patients
This research study is studying a cancer vaccine called Dendritic Cell/AML Fusion vaccine (DC/AML vaccine) as a possible treatment for Acute Myelogenous Leukemia (AML). The interventions involved in this study are: * Dendritic Cell/AML Fusion vaccine (DC/AML vaccine) * Decitabine, a chemotherapy drug
• 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