NCT03059485

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

A Randomized Phase II Clinical Trial of Dendritic Cell/AML Fusion Cell Vaccine Versus Observation in Patients Who Achieve a Chemotherapy-induced Remission

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myelogenous Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	DC/AML Fusion Vaccine	The Dendritic Cell Fusion Vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells
OTHER	Observation	Traditional care provided by the hospital.

Timeline

• Start date: 2017-06-01
• Primary completion: 2026-09-04
• Completion: 2026-12-04
• First posted: 2017-02-23
• Last updated: 2026-02-04

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study