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

Acute Myelogenous Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116467
• Other study ID #: K-0009
• Secondary ID: K-0009
• Status: Completed
• Phase: Phase 2
• First received: June 29, 2005
• Last updated: December 18, 2007
• Start date: March 2001
• Est. completion date: January 2006

Study information

• Verified date: December 2007
• Source: Cell Genesys
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• GVAX leukemia vaccine (therapeutic cellular vaccine, GM-CSF producing)

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Cell Genesys

Country where clinical trial is conducted

United States,