Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2026-01-16 @ 11:12 PM
Study NCT ID:
NCT03679650
Status:
RECRUITING
Last Update Posted:
2025-01-24
First Post:
2018-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dendritic Cell/AML Fusion Cell Vaccine Following Allogeneic Transplantation in AML Patients
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Study Overview
Official Title:
A Phase I Clinical Trial of Dendritic Cell/AML Fusion Cell Vaccine Alone and in Conjunction With Decitabine Following Allogeneic Transplantation in AML Patients
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
The interventions involved in this study are:
* Dendritic Cell/AML Fusion vaccine (DC/AML vaccine)
* Decitabine, a chemotherapy drug
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1P50CA206963-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |