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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00116467
First Posted: June 30, 2005
Last Update Posted: December 24, 2007
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.
Information provided by:
Cell Genesys
  Purpose
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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
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): NCT00116467


Locations
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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00116467     History of Changes
Other Study ID Numbers: K-0009
First Submitted: June 29, 2005
First Posted: June 30, 2005
Last Update Posted: December 24, 2007
Last Verified: December 2007

Keywords provided by Cell Genesys:
AML
Acute Myelogenous Leukemia
GVAX
Vaccine
Stem Cell Transplant
Autologous

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs