Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission
- This study is divided into two groups: Group 1 participants will receive the DC AML
Fusion Vaccine and Group 2 participants will receive the CT-011 and the DC AML vaccine.
The first 10 participants will be in Group 1 and the remaining 25 will be in Group 2.
- Group 1 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 in this group will receive 3 doses of
the vaccine at 4 week intervals.
- Group 2 participants will receive infusions of CT-011 4-8 weeks after completion of
chemotherapy for AML. Participants in this group will receive a total of 3 doses of
CT-011 at 6 week intervals. In addition, they will receive a vaccination of the DC AML
vaccine two weeks following each infusion of CT-011.
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
First Stage: To assess the toxicity associated with treating AML patients with DC AML fusion cells in the post-chemotherapy setting
Jacalyn Rosenblatt, MD
Beth Israel Deaconess Medical Center
United States: Food and Drug Administration
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