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

Running, not enrolling · Phase 1

Conditions studied: Acute Myelogenous Leukemia

In brief

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

Key facts

Study ID

NCT03679650

Run by

Beth Israel Deaconess Medical Center

People needed

28

Starts

2018-10-11

Expected to finish

2026-08-31

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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