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

Cell Genesys

Status and phase: Completed; Phase 2

Conditions: Acute Myelogenous Leukemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00116467

K-0009

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)