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

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. Identifier: NCT00116467
Recruitment Status : Completed
First Posted : June 30, 2005
Last Update Posted : December 24, 2007
Information provided by:
Cell Genesys

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Biological: GVAX leukemia vaccine (therapeutic cellular vaccine, GM-CSF producing) Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 55 participants
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
Study Start Date : March 2001
Actual Study Completion Date : January 2006

Information from the National Library of Medicine

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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.

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 identifier (NCT number): NCT00116467

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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
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00116467    
Other Study ID Numbers: K-0009
First Posted: June 30, 2005    Key Record Dates
Last Update Posted: December 24, 2007
Last Verified: December 2007
Keywords provided by Cell Genesys:
Acute Myelogenous Leukemia
Stem Cell Transplant
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs