Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Cell Genesys
ClinicalTrials.gov Identifier:
NCT00116467
First received: June 29, 2005
Last updated: December 18, 2007
Last verified: December 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Cell Genesys

Additional 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, K-0009
Study First Received: June 29, 2005
Last Updated: December 18, 2007
Health Authority: United States: Food and Drug Administration

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
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014