Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission
|ClinicalTrials.gov Identifier: NCT01096602|
Recruitment Status : Active, not recruiting
First Posted : March 31, 2010
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia AML||Biological: DC AML Vaccine||Phase 2|
- On this study participants will receive the DC AML vaccine and GM-CSF 4-8 weeks after completion of chemotherapy for acute myelogenous leukemia (AML). GM-CSF is a drug that stimulates white blood cells and is given with the DC AML Vaccine in an effort to enhance the effect of the vaccine. Participants will receive 2-3 doses of the vaccine at 4 week intervals.
- All participants will undergo the following procedures: Isolation of tumor cells by either bone marrow biopsy or blood draw; Initial chemotherapy for AML with standard therapy; Leukopheresis (collection of white blood cells from the blood).
- All participants will also have blood tests, a physical exam, and an electrocardiogram prior to each dose of vaccine.
- Four weeks following the final vaccination, participants will undergo a skin test called "delayed-type hypersensitivity" (DTH). This is an injection of the tumor cells under the skin to measure how the immune system responds. The tumor cells are broken up and irradiated to prevent their growth.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2024|
Experimental: Group 1
DC AML Fusion Vaccine
Biological: DC AML Vaccine
Group 1: 2-3 doses of the vaccine at 4 week intervals
- Toxicity [ Time Frame: 2 years ]To assess the toxicity associated with treating AML patients with DC/AML fusion cells in the post-chemotherapy setting
- Immune Response [ Time Frame: 2 years ]To explore immunological response to DC/AML fusion vaccination in patients who have achieved a chemotherapy-induced remission.
- T-cell and Immune Response [ Time Frame: 2 years ]To correlate levels of circulating activated and regulatory T cells with immunologic response
- Disease Response [ Time Frame: 2 years ]To define anti-tumor effects by determining time to disease progression.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096602
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Jacalyn Rosenblatt, MD||Beth Israel Deaconess Medical Center|