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Sponsored by: |
Cell Genesys |
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Information provided by: | Cell Genesys |
ClinicalTrials.gov Identifier: | NCT00116467 |
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 |
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Acute Myelogenous Leukemia |
Biological: GVAX leukemia vaccine (therapeutic cellular vaccine, GM-CSF producing) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | K-0009, K-0009 |
Study First Received: | June 29, 2005 |
Last Updated: | December 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00116467 |
Health Authority: | United States: Food and Drug Administration |
AML Acute Myelogenous Leukemia GVAX |
Vaccine Stem Cell Transplant Autologous |
Leukemia Acute myelogenous leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia |
Neoplasms Neoplasms by Histologic Type |