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

Phase 2

Recruiting

• Conditions: Acute Myelogenous Leukemia
• Interventions: Biological: DC/AML Fusion Vaccine; Other: Observation

• Registration Number: NCT03059485
• Lead Sponsor: Beth Israel Deaconess Medical Center

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)

Detailed Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

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

The FDA (the U.S. Food and Drug Administration) has not approved durvalumab as a treatment for AML.

In this research study, the investigators are determining if the DC/AML vaccine can be used safely in subjects with acute leukemia after finishing chemotherapy, and whether the DC/AML vaccine is capable of producing immune responses against leukemia alone. 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 Dendritic Cell Fusion 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.

Study Timeline

• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-23
• Study Start: 2017-06-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-16
• Last Update Posted: 2023-06-18
• Primary Completion: 2025-05-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DC/AML Vaccine	Observation	- Patients will be vaccinated with DC/AML Fusion Vaccine
DC/AML Vaccine	DC/AML Fusion Vaccine	- Patients will be vaccinated with DC/AML Fusion Vaccine
Observation	Observation	- Patients will be monitored with routine labs and bone marrow biopsies

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	2 years

Secondary Outcome Measures

Name	Time	Method
Assessing Toxicity using CTCAE version 4.03	2 years
Overall Survival	2 years

Trial Locations

Locations (4)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Wisconsin Carbone Cancer Center; 🇺🇸 Madison, Wisconsin, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States