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A Study of Active Immunotherapy With GRNVAC1 in Patients With Acute Myelogenous Leukemia (AML)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00510133
Recruitment Status : Completed
First Posted : August 1, 2007
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Asterias Biotherapeutics, Inc.

Study Description
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Brief Summary:
This is a phase II study to evaluate the safety, feasibility and efficacy of immunotherapy with GRNVAC1 in patients with AML.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Biological: GRNVAC1 Phase 2

Detailed Description:
This is a multicenter, open-label evaluation of feasibility, safety and immunotherapy in patients with AML in complete clinical remission. Patients will undergo leukapheresis prior to or shortly after completing consolidation chemotherapy. Dendritic cells will be transfected with the messenger RNA encoding human telomerase reverse transcriptase (hTERT) and a portion of the lysosome-associated membrane protein LAMP-1 (LAMP), matured, aliquoted, and cryopreserved. The final autologous vaccine product is referred to as GRNVAC1. Patients will be vaccinated with weekly for 6 weeks,will "rest" for 4 weeks, then will receive 6 boost injections, each administered every other week for 12 weeks. Patients will be followed every 4 weeks until Week 54, then every 3 months for 1 year, then every 6 months up to approximately 5 years from the first vaccination or until relapse/progression.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Active Immunotherapy With GRNVAC1, Autologous Mature Dendritic Cells Transfected With mRNA Encoding Human Telomerase Reverse Transcriptase, in Patients With Acute Myelogenous Leukemia in Complete Clinical Remission
Study Start Date : July 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: GRNVAC1
Autologous dendritic cell vaccine
 Biological: GRNVAC1
Autologous dendritic cell vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility will be assessed by examining whether enough cells are collected during leukapheresis, whether enough vaccine is manufactured for at least 2 injections, and whether the patient is still in remission when the vaccine is released. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Immunological response, defined as the proportion of patients with a positive induction of hTERT-specific T cells to twice the pre-vaccination level, the proportion of patients with DTH, and event-free survival. [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • AML in first complete remission (CR1) or in second complete remission (CR2) with CR1 >/= 6 months
  • Has completed at least one cycle of consolidation chemotherapy within past 6 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate hepatic/renal function

Exclusion Criteria:

  • CR1 and good risk cytogenetic features [t(15;17), t(8;21), inv(16) or t(16:16)]
  • Central nervous system or leptomeningeal disease
  • Allogeneic stem cell transplant planned or expected
  • Documented allergy to penicillin or beta-lactam antibiotics
  • Active or ongoing autoimmune disease
  • Clinically significant pulmonary or cardiovascular disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510133


Locations
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United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Missouri
Washington University School of Medicine, Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Asterias Biotherapeutics, Inc.
Investigators
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Principal Investigator: John F DiPersio, MD,PhD Washington University School of Medicine
More Information
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Additional Information:

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Responsible Party: Asterias Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00510133    
Other Study ID Numbers: GRNVAC1 CP06-151
First Posted: August 1, 2007    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms