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

This study has been completed.
Information provided by:
Cell Genesys Identifier:
First received: June 29, 2005
Last updated: December 18, 2007
Last verified: December 2007
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 leukemia vaccine in subjects with acute myelogenous leukemia (AML).

Condition Intervention Phase
Acute Myelogenous Leukemia Biological: GVAX leukemia vaccine (therapeutic cellular vaccine, GM-CSF producing) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia: The Use of Autologous Tumor Cells With an Allogeneic GM-CSF Producing Cell Line

Resource links provided by NLM:

Further study details as provided by Cell Genesys:

Estimated Enrollment: 55
Study Start Date: March 2001
Study Completion Date: January 2006

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Initial diagnosis of de novo AML with no preexisting hematologic dysplasia for more than 3 months.
  • No prior therapy except leukapheresis or less than 72 hours of hydroxyurea.

Exclusion Criteria:

  • Prior myelodysplastic disorder, or treatment-related leukemia.
  • Prior myeloproliferative disease.
  • Acute promyelocytic leukemia (APL).
  • Prior chemotherapy for a malignant or nonmalignant disorder.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00116467

United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Cell Genesys
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00116467     History of Changes
Other Study ID Numbers: K-0009
Study First Received: June 29, 2005
Last Updated: December 18, 2007

Keywords provided by Cell Genesys:
Acute Myelogenous Leukemia
Stem Cell Transplant

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs processed this record on August 18, 2017