Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
The Vaccine Company
OBJECTIVES: Primary * Compare improvement of overall survival of patients with acute myeloid leukemia treated with PR1 leukemia peptide vaccine and sargramostim (GM-CSF) vs placebo vaccine and GM-CSF. Secondary * Compare improvement of relapse-free survival of patients treated with these regimens. * Compare remission duration in patients treated with these regimens. * Compare immune response, as measured by PR1-HLA-A2 tetramer assay, in patients treated with these regimens. OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are stratified according to age and complete remission (CR) (≥ 18 years of age and in second CR vs ≥ 55 years of age and in first CR), type of acute myeloid leukemia (de novo vs secondary), and cytogenetics (unfavorable vs favorable and intermediate). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive PR1 leukemia peptide vaccine and sargramostim (GM-CSF) subcutaneously (SC). * Arm II: Patients receive placebo vaccine and GM-CSF SC. PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
