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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Myelogenous Leukemia
• Intervention / Treatment: Biological: DC/AML fusion cells

Detailed Description

This research study is a Phase I clinical trial, which tests the safety of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. This study is investigating the DC/AML vaccine with and without the drug decitabine as a possible treatment for AML in the post-transplant setting.

The FDA (the U.S. Food and Drug Administration) has not approved the DC/AML vaccine as a treatment for any disease.

The FDA has approved decitabine as a treatment option for this disease.

The FDA has not approved the combination of the DC/AML vaccine with decitabine as a treatment option for any disease,

In this research study, the investigators are determining if the DC/AML vaccine can be used safely in subjects with acute leukemia after they have undergone a transplant, and whether the DC/AML vaccine alone is capable of producing immune responses against leukemia. Cancer cells are foreign to the body and have unique markers that distinguish them from normal cells.

These markers can potentially serve as targets for the immune system. An immune response is any reaction by the immune system; a complex system that is responsible for distinguishing us from everything foreign to us, and for protecting us against infections and foreign substances.

The DC/AML vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells. Unlike a standard vaccine that is used to prevent infections, cancer vaccines are being studied to see if they can fight cancers that are already in the body. Laboratory studies have shown that when dendritic cells and tumor cells are brought together, the dendritic cells can stimulate immune responses against the tumor and, in some cases, cause the tumor to shrink.

Decitabine is thought to act as an anti-metabolite. It seems to work by having a toxic effect on the abnormal bone marrow cells. It also appears to affect the DNA in genes that control cell growth. This promotes normal specialization and blood cell growth, so that the body is better able to make red blood cells, white blood cells, and platelets.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AML Patient who are undergoing allogeneic transplantation; 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	Biological: DC/AML fusion cells; An investigational agent that tries to help the immune system to recognize and fight against cancer cells
Experimental: AML Patient who are undergoing transplantation; 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	Biological: DC/AML fusion cells; An investigational agent that tries to help the immune system to recognize and fight against cancer cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Remission	Patients in complete remission	12 months
Complete Remission with Incomplete Count Recovery	Patients in complete remission with incomplete count recovery	12 Months
Complete Remission with Incomplete Platelet Recovery	Patients in complete remission with incomplete platelet recovery	12 months
Partial Remission (PR)	Patients in Partial Remission	12 months
Rate of Relapse	Rate of relapse seen in patients	12 months
Stable Disease	Patients with stable disease	12 Months
Relapse free survival	Patients with relapse free survival	12 Months

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: National Cancer Institute (NCI); Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Jacalyn Rosenblatt, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2018
• Primary Completion (Actual): March 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 20, 2018

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: AML
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Decitabine
• Other Study ID Numbers: 18-202; 1P50CA206963-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No