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

NCT03679650 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 18-2021P50CA206963-01A1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Acute Myelogenous Leukemia

Keywords

AML

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Complete Remission

  12 months

• Complete Remission with Incomplete Count Recovery

  12 Months

• Complete Remission with Incomplete Platelet Recovery

  12 months

• Partial Remission (PR)

  12 months

• Rate of Relapse

  12 months

Study Arms (2)

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

Biological: DC/AML fusion cells

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

Biological: DC/AML fusion cells

Interventions

DC/AML fusion cells BIOLOGICAL

An investigational agent that tries to help the immune system to recognize and fight against cancer cells

AML Patient who are undergoing allogeneic transplantation; AML Patient who are undergoing transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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

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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Cancer Institute (NCI): collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jacalyn Rosenblatt, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 20, 2018
• Study Start: October 11, 2018
• Primary Completion: March 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)