NCT01096602|CompletedPhase 2ResultsDMC
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Sponsor study identifier
interventional
63
1 country
1
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2023
Actual (reported)Study Completion
June 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 29, 2010
Actual (reported)March 31, 2010
Actual (reported)May 2010
Date type not reportedThis date has not been verified as actual or estimated.
December 2023
Actual (reported)June 2025
Actual (reported)July 14, 2026
Actual (reported)Number of Participants With Adverse Events Associated With DC/AML Tumor Vaccine
Participants were assessed for adverse events associated with treating AML patients with DC/AML fusion cells in the post-chemotherapy setting. Adverse event monitoring occurred monthly through 6 months following the last vaccine (up to 9 months) or until time of disease progression (whichever occurred first.)
6 months after the last vaccine, up to 9 months
Immune Expansion After Vaccination
6 months after last vaccine, up to 9 months
Number of Patients Who Had Expansion of Leukemia-Specific CD4 and CD8 T-cells After Vaccination
6 months after last vaccine, up to 9 months
Disease Response
2 years
DC AML Fusion Vaccine
Group 1: 2-3 doses of the vaccine at 4 week intervals
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Shallis RM, Podoltsev NA. Maintenance therapy for acute myeloid leukemia: sustaining the pursuit for sustained remission. Curr Opin Hematol. 2021 Mar 1;28(2):110-121. doi: 10.1097/MOH.0000000000000637.
Jacalyn Rosenblatt, MD
Beth Israel Deaconess Medical Center
63 participants (actual enrollment reported by the registry).
First Submitted
March 29, 2010
First Posted
March 31, 2010
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
DC/AML Fusion Cell Vaccine vs Observation in Patients Who Achieve a Chemotherapy-induced Remission
Contact the study team to confirm eligibility.
Primary Completion
December 2023
Actual (reported)Study Completion
June 2025
Actual (reported)Last Updated
July 14, 2026
Results First Posted
July 14, 2026
Record last verified: 2026-07
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Source: ClinicalTrials.gov.
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