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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Dana-Farber Cancer Institute
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Medivation, Inc.
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Jacalyn Rosenblatt, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01096602
First received: March 29, 2010
Last updated: August 30, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Acute Myelogenous Leukemia
AML
Biological: DC AML Vaccine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To assess the toxicity associated with treating AML patients with DC/AML fusion cells in the post-chemotherapy setting


Secondary Outcome Measures:
  • Immune Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To correlate levels of circulating activated and regulatory T cells with immunologic response

  • Disease Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To define anti-tumor effects by determining time to disease progression.


Estimated Enrollment: 75
Study Start Date: May 2010
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
DC AML Fusion Vaccine
Biological: DC AML Vaccine
Group 1: 2-3 doses of the vaccine at 4 week intervals

Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Screening:

  • Patients with AML at initial diagnosis or at first relapse
  • 18 years of age or older
  • ECOG Performance Status 0-2
  • Life expectancy of greater than 9 weeks
  • Laboratory values within limits outlined in the protocol
  • Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation

Prior to Cell Collections for Dendritic Cell Generation:

  • Patients must have obtained complete remission with chemotherapy defined by the absence of circulating blasts, and less then 5% blasts on bone marrow examination following hematopoietic recovery
  • Resolution of all chemotherapy related Grade III-IV toxicity as per CTC criteria 4.0
  • Laboratory values as outlined in the protocol
  • For patients with evidence of minimal residual disease prior to vaccination, assessment of minimal residual disease status by cytogenetics or FISH will be followed post vaccination

Prior to Post-Chemotherapy Immunotherapy:

  • Resolution of all chemotherapy related grade III-IV toxicity
  • Laboratory values as outlined in the protocol
  • At least 2 doses of fusion vaccine produced

Exclusion Criteria:

Screening:

  • Active or history of autoimmune disorders/conditions including Type 1 diabetes. Type II diabetes, vitiligo or stable hyperthyroidism will not be considered exclusion criteria
  • HIV positive
  • Significant cardiac disease characterized by symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia
  • Pregnant women
  • Individuals with a history of a different malignancy are ineligible except for circumstances outlined in the protocol document

Prior to Cell Collection for Dendritic Cell Generation:

  • Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
  • Patients who choose to proceed with allogeneic or autologous transplant at the time of remission will not be vaccinated and will come off study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096602

Contacts
Contact: Jacalyn Rosenblatt, MD 617-667-9920 jrosenb1@bidmc.harvard.edu
Contact: Emma Logan, BSN, RN 617-667-5984 eklogan@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institutes of Health (NIH)
Medivation, Inc.
The Leukemia and Lymphoma Society
Investigators
Principal Investigator: Jacalyn Rosenblatt, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Jacalyn Rosenblatt, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01096602     History of Changes
Other Study ID Numbers: 09-412 
Study First Received: March 29, 2010
Last Updated: August 30, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Dendritic Cell/AML vaccine
CT-011

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016