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

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

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).

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.