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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Asterias Biotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00510133
First received: July 30, 2007
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Acute Myelogenous Leukemia
Biological: GRNVAC1
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: 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

Resource links provided by NLM:


Further study details as provided by Asterias Biotherapeutics, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: July 2007
Estimated Study Completion Date: February 2015
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GRNVAC1
Autologous dendritic cell vaccine
Biological: GRNVAC1
Autologous dendritic cell vaccine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510133

Locations
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
St. 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
Principal Investigator: John F DiPersio, MD,PhD Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Asterias Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00510133     History of Changes
Other Study ID Numbers: GRNVAC1 CP06-151
Study First Received: July 30, 2007
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014