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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Medivation, Inc. | INDUSTRY |
| The Leukemia and Lymphoma Society | OTHER |
| Dana-Farber Cancer Institute |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | DC AML Fusion Vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC AML Vaccine | Biological | Group 1: 2-3 doses of the vaccine at 4 week intervals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | To assess the toxicity associated with treating AML patients with DC/AML fusion cells in the post-chemotherapy setting | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Response | To explore immunological response to DC/AML fusion vaccination in patients who have achieved a chemotherapy-induced remission. | 2 years |
| T-cell and Immune Response | To correlate levels of circulating activated and regulatory T cells with immunologic response |
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Inclusion Criteria:
Screening:
Prior to Cell Collections for Dendritic Cell Generation:
Prior to Post-Chemotherapy Immunotherapy:
Exclusion Criteria:
Screening:
Prior to Cell Collection for Dendritic Cell Generation:
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| Name | Affiliation | Role |
|---|---|---|
| Jacalyn Rosenblatt, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33394722 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 23, 2025 | |
| Reset | Feb 12, 2025 | |
| Release | Apr 8, 2026 | |
| Reset | Apr 28, 2026 | |
| Release | May 11, 2026 | |
| Reset | Jun 4, 2026 | |
| Release | Jun 11, 2026 | |
| Reset | Jul 7, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 23, 2025 | Feb 12, 2025 | |||
| Apr 8, 2026 |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| OTHER |
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| 2 years |
| Disease Response | To define anti-tumor effects by determining time to disease progression. | 2 years |
| Apr 28, 2026 |
| May 11, 2026 | Jun 4, 2026 |
| Jun 11, 2026 | Jul 7, 2026 |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |