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
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Overall survival
No
Craig S. Rosenfeld, MD
Study Chair
The Vaccine Company
United States: Food and Drug Administration
CDR0000510853
NCT00454168
May 2005
Name | Location |
---|---|
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 |