Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission
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) alone, as well as of the combination of CT-011, after participants have achieved a remission with chemotherapy. In this clinical trial, patients are treated with a tumor vaccine alone or in combination with CT-O11, an investigational monoclonal antibody that may augment response to vaccination. Monoclonal antibodies are known to target specific cells (in this case, cells in the immune system). This immunotherapy may help to control leukemic cells that are resistant to chemotherapy and prevent disease recurrence. 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 the combination of DC AML vaccine and CT-011 will prevent or delay the disease from coming back.
Acute Myelogenous Leukemia
Biological: DC AML Vaccine
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission|
- Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]First Stage: To assess the toxicity associated with treating AML patients with DC AML fusion cells in the post-chemotherapy setting
- Toxicity [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]Second Stage: To assess the toxicity associated with treating AML patients with a combination of DC AML fusion cells and CT-011 following a chemotherapy induced remission
- Immune response [ Time Frame: 2 years ] [ Designated as safety issue: No ]First Stage: To explore immunological response to DC AML Fusion vaccination in this patient population.
- Tumor regression [ Time Frame: 2 years ] [ Designated as safety issue: No ]Second stage: To determine if cellular immunity is induced by treatment with monoclonal antibody CT-011 and DC/AML fusion cells in patients who have obtained a complete remission following induction chemotherapy.
- Time to disease progression [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Second Stage: To define anti-tumor effects by determining time to disease progression.
|Study Start Date:||May 2010|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: Group 1
DC AML Fusion Vaccine
Biological: DC AML Vaccine
Group 1: 3 doses of the vaccine at 4 week intervals Group 2: Given two weeks following CT-011 infusion
Experimental: Group 2
CT-011 and DC AML Vaccine
Biological: DC AML Vaccine
Group 1: 3 doses of the vaccine at 4 week intervals Group 2: Given two weeks following CT-011 infusionDrug: CT-011
Infusion given at 6 week intervals for a total of 3 doses
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096602
|Contact: Jacalyn Rosenblatt, MDfirstname.lastname@example.org|
|Contact: Emma Breaultemail@example.com|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Jacalyn Rosenblatt, MD||Beth Israel Deaconess Medical Center|