Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission

2014-08-27 03:14:52 | BioPortfolio


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.


- 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Acute Myelogenous Leukemia


DC AML Vaccine, CT-011


Beth Israel Deaconess Medical Center
United States




Dana-Farber Cancer Institute

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:14:52-0400

Clinical Trials [4364 Associated Clinical Trials listed on BioPortfolio]

Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia

The purpose of this study is to evaluate clinical and laboratory safety associated with the administration of GVAX leukemia vaccine and to determine the feasibility of generation of GVAX l...

Study of Vaccination With Autologous Acute Myeloblastic Leukemia Cells in Patients With Advanced Myelodysplasia or Acute Myelogenous Leukemia

The purpose of this study is to test the safety of a new investigational acute myeloblastic leukemia (AML) vaccine and see what effects (good and bad) it has on patients with advanced myel...

Investigation of Clofarabine in Acute Leukemias

The goals and objectives of this project are to evaluate the antileukemic activity of the investigational agent clofarabine in patients with acute myelogenous leukemia (AML), acute lymphoc...

A Phase I Clinical Trial of Dendritic Cell/AML Fusion Cell Vaccine Alone and in Conjunction With Decitabine Following Allogeneic Transplantation in AML Patients

This research study is studying a cancer vaccine called Dendritic Cell/AML Fusion vaccine (DC/AML vaccine) as a possible treatment for Acute Myelogenous Leukemia (AML). The interventions ...

Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia

The purpose of this study is to determine how effective, and to what extent, Iressa is in the treatment of acute myelogenous leukemia.

PubMed Articles [7906 Associated PubMed Articles listed on BioPortfolio]

Novel benzobfurans with anti-microtubule activity upregulate expression of apoptotic genes and arrest leukemia cells in G2/M phase.

Novel derivatives of benzo[b]furan were found to be highly toxic towards human chronic myelogenous (K562), acute myelogenous (HL-60) and acute lymphoblastic (MOLT-4) leukemia cells.

RUNX1 Mutations Can Lead to Aberrant Expression of CD79a and PAX5 in Acute Myelogenous Leukemias: A Potential Diagnostic Pitfall.

RUNX1 is a crucial transcription factor for hematological stem cells and well-known for its association with acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML). Besides the transl...

Blast-Cell Arterial Embolus in Acute Myelogenous Leukemia.

The link between coagulatory dysfunction in acute leukemias is well known, with patients having an increased risk of bleeding as well as thrombosis. Arterial thrombosis is particularly rare in this po...

Importance of Acute Lymphoblastic Leukemia-type Therapy for Bilineal Acute Leukemia.

We examined 3 pediatric patients with bilineal acute leukemia. Patient 1 with B-cell acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML) with B-ALL dominance responded well to pred...

ZNF224 is a transcriptional repressor of AXL in chronic myeloid leukemia cells.

ZNF224 is a KRAB-zinc finger transcription factor that exerts a key tumor suppressive role in chronic myelogenous leukemia. In this study, we identify the receptor tyrosine kinase Axl as a novel targe...

Medical and Biotech [MESH] Definitions

A rare acute myeloid leukemia characterized by abnormal EOSINOPHILS in the bone marrow.

An acute myeloid leukemia in which abnormal PROMYELOCYTES predominate. It is frequently associated with DISSEMINATED INTRAVASCULAR COAGULATION.

An acute leukemia exhibiting cell features characteristic of both the myeloid and lymphoid lineages and probably arising from MULTIPOTENT STEM CELLS.

Conditions in which the abnormalities in the peripheral blood or bone marrow represent the early manifestations of acute leukemia, but in which the changes are not of sufficient magnitude or specificity to permit a diagnosis of acute leukemia by the usual clinical criteria.

An acute myeloid leukemia in which 80% or more of the leukemic cells are of monocytic lineage including monoblasts, promonocytes, and MONOCYTES.

More From BioPortfolio on "Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission"

Quick Search


Relevant Topic

An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...

Searches Linking to this Trial