Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia
Sponsor
Cell Genesys (Industry)
Overall Status
Completed
CT.gov ID
NCT00116467
Collaborator
(none)
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Study Details
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
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
Study Start Date
:
Mar 1, 2001
Actual Study Completion Date
:
Jan 1, 2006
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of California, San Francisco | San Francisco | California | United States | 94143 |
2 | University of Chicago | Chicago | Illinois | United States | 60637 |
3 | Johns Hopkins University | Baltimore | Maryland | United States | 21231 |
4 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Cell Genesys
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00116467
Other Study ID Numbers:
- K-0009
- K-0009
First Posted:
Jun 30, 2005
Last Update Posted:
Dec 24, 2007
Last Verified:
Dec 1, 2007
Keywords provided by ,
,
Additional relevant MeSH terms: