DC/AML Fusion Cell Vaccine vs Observation in Patients Who Achieve a Chemotherapy-induced Remission

NCT03059485 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 16-593
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 4

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)

Conditions

Acute Myelogenous Leukemia

Keywords

Leukemia

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  2 years

Secondary Outcomes (2)

• Overall Survival

  2 years

• Assessing Toxicity using CTCAE version 4.03

  2 years

Study Arms (2)

DC/AML Vaccine

EXPERIMENTAL

\- Patients will be vaccinated with DC/AML Fusion Vaccine

Biological: DC/AML Fusion Vaccine; Other: Observation

Observation

EXPERIMENTAL

\- Patients will be monitored with routine labs and bone marrow biopsies

Other: Observation

Interventions

DC/AML Fusion Vaccine BIOLOGICAL

The Dendritic Cell Fusion Vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells

DC/AML Vaccine

Observation OTHER

Traditional care provided by the hospital.

DC/AML Vaccine; Observation

Eligibility Criteria

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

You may qualify if:

• Patients must have AML at initial diagnosis or at first relapse
• Patients must be ≥ 55 years old
• ECOG performance status ≤2 (Appendix A)
• Patients must have normal organ and marrow function as defined below:
• total bilirubin ≤ 2.0 mg/dL AST(SGOT)/ALT(SGPT) ≤3 × institutional upper limit of normal creatinine ≤ 2.0 mg/dl
• 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.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Active or prior documented autoimmune or inflammatory disorders including but not limited to the following:
• GI Disorders: (including inflammatory bowel disease \[eg, ulcerative colitis, Crohn's disease\], diverticulitis (with the exception of a prior episode that has resolved), celiac disease, or other serious gastrointestinal chronic conditions associated with diarrhea.
• Systemic lupus erythematosus
• Wegener's syndrome \[granulomatosis with polyangiitis\]
• Myasthenia gravis
• Graves' disease
• Rheumatoid arthritis
• Hypophysitis
• Uveitis
• The following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatment..
• Because of compromised cellular immunity, patients who have a Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).
• Patients must not have significant cardiac disease characterized by symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia
• 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.
• Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: non-invasive cancer (such as, any in situ cancers) and basal cell or squamous cell carcinoma of the skin.
• Prior allogeneic transplant

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Celgene: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Jacalyn Rosenblatt, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jacalyn Rosenblatt, MD

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 23, 2017
• Study Start: June 1, 2017
• Primary Completion (Estimated): September 4, 2026
• Study Completion (Estimated): December 4, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)