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

• Status: Recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Azacitidine; Decitabine; Vaccines

Criteria

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