Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia
Phase 2
Completed
- Conditions
- Acute Myelogenous Leukemia
- Registration Number
- NCT00116467
- Lead Sponsor
- Cell Genesys
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States