Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission
NCT01096602 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63
Last updated 2024-11-07
Summary
Acute myelogenous leukemia (AML) arises from leukemia stem cells that are difficult to eradicate and serve as a reservoir for disease relapse following chemotherapy. A promising area of investigation is the development of immunotherapeutic approaches that stimulate the immune system to recognize leukemia stem cells as foreign and eliminate them. The purpose of this research study is to determine the safety of the Dendritic Cell AML Fusion Vaccine (DC AML vaccine) after participants have achieved a remission with chemotherapy. In this clinical trial, patients are treated with a tumor vaccine alone following standard of care chemotherapy. The DC AML vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells. It is hoped that DC AML vaccine will prevent or delay the disease from coming back.
Conditions
- Acute Myelogenous Leukemia
- AML
Interventions
- BIOLOGICAL
-
DC AML Vaccine
Group 1: 2-3 doses of the vaccine at 4 week intervals
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
Medivation, Inc.
collaborator INDUSTRY -
The Leukemia and Lymphoma Society
collaborator OTHER - collaborator OTHER
-
Beth Israel Deaconess Medical Center
lead OTHER
Principal Investigators
-
Jacalyn Rosenblatt, MD · Beth Israel Deaconess Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-05-31
- Primary Completion
- 2023-12-31
- Completion
- 2024-06-30
Countries
- United States
Study Locations
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