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

History of Changes

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:

Genetics Home Reference related topics: familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acute Myeloid Leukemia Cancer Leukemia

Drug Information available for: Sargramostim

U.S. FDA Resources

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

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):

Borrello IM, Levitsky HI, Stock W, Sher D, Qin L, DeAngelo DJ, Alyea EP, Stone RM, Damon LE, Linker CA, Maslyar DJ, Hege KM. Granulocyte-macrophage colony-stimulating factor (GM-CSF)-secreting cellular immunotherapy in combination with autologous stem cell transplantation (ASCT) as postremission therapy for acute myeloid leukemia (AML). Blood. 2009 Aug 27;114(9):1736-45. Epub 2009 Jun 25.

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, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013

To Top