CELL INTELLIGENCE · 肿瘤细胞治疗研究

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

主要终点：The fold-increase in AML specific T cells in peripheral blood and bone marrow · The fold-increase in AML specific T cells in the peripheral blood and bone marrow · 12 months
次要终点：Complete Remission；Complete Remission with Incomplete Count Recovery；Complete Remission with Incomplete Platelet Recovery；Partial Remission (PR)；Rate of Relapse；Stable Disease；Relapse free survival

• AML Patient who are undergoing allogeneic transplantation · EXPERIMENTAL · * Patients will be vaccinated with DC/AML fusion cells * Four days of GM-CSF given subcutaneously at the site of vaccination * Patients will receive 2 vaccines, 3 weeks apart, with the potential for a booster vaccine * Patients will be treated with 5 days of decitabine in the post-transplant setting
• AML Patient who are undergoing transplantation · EXPERIMENTAL · * Patients will be vaccinated with DC/AML fusion cells * Four days of GM-CSF given subcutaneously at the site of vaccination * Patients will receive 2 vaccines, 3 weeks apart, with the potential for a booster vaccine

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