A Phase 3, Randomized, Double-Blind, Multicenter Study of Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF in Elderly Patients With AML in First Complete Remission or Adults in Second Complete Remission: A Pivotal Study
- 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
- 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)
- Arm II: Patients receive placebo vaccine and GM-CSF SC.
PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Craig S. Rosenfeld, MD
The Vaccine Company
United States: Food and Drug Administration
|Mayo Clinic Scottsdale||Scottsdale, Arizona 85259|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center||Kansas City, Kansas 66160-7353|
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|
|Greenebaum Cancer Center at University of Maryland Medical Center||Baltimore, Maryland 21201|
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|
|Indiana University Melvin and Bren Simon Cancer Center||Indianapolis, Indiana 46202-5289|
|UPMC Cancer Centers||Pittsburgh, Pennsylvania 15232|
|Rush Cancer Institute at Rush University Medical Center||Chicago, Illinois 60612|
|Vaccine Company||South San Francisco, California 94080|
|St. Francis Hospital Cancer Care Services||Indianapolis, Indiana 46237|
|Cancer Care Centers of South Texas - Southeast||San Antonio, Texas 78222|