Back to resultsVaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia
Primary Purpose
Acute Myelogenous Leukemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GVAX leukemia vaccine (therapeutic cellular vaccine, GM-CSF producing)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring AML, Acute Myelogenous Leukemia, GVAX, Vaccine, Stem Cell Transplant, Autologous
Eligibility 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.
Sites / Locations
- University of California, San Francisco
- University of Chicago
- Johns Hopkins University
- Dana Farber Cancer Institute
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00116467
Brief Title
Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cell Genesys
4. Oversight
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia
Keywords
AML, Acute Myelogenous Leukemia, GVAX, Vaccine, Stem Cell Transplant, Autologous
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
GVAX leukemia vaccine (therapeutic cellular vaccine, GM-CSF producing)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19556425
Citation
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. doi: 10.1182/blood-2009-02-205278. Epub 2009 Jun 25.
Results Reference
derived
Learn more about this trial
Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia
We'll reach out to this number within 24 hrs