Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in Remission
- Conditions
- Leukemia
- Interventions
- Biological: PR1 leukemia peptide vaccineBiological: sargramostimOther: placebo
- Registration Number
- NCT00454168
- Lead Sponsor
- The Vaccine Company
- Brief Summary
RATIONALE: Vaccines made from a peptide may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may be an effective treatment for acute myeloid leukemia. It is not yet known whether giving vaccine therapy together with GM-CSF is more effective than giving placebo together with GM-CSF in treating acute myeloid leukemia.
PURPOSE: This randomized phase III trial is studying vaccine therapy and GM-CSF to see how well they work compared with a placebo and GM-CSF in treating patients with acute myeloid leukemia in remission.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 244
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm I PR1 leukemia peptide vaccine Patients receive PR1 leukemia peptide vaccine and sargramostim (GM-CSF) subcutaneously. Arm I sargramostim Patients receive PR1 leukemia peptide vaccine and sargramostim (GM-CSF) subcutaneously. Arm II sargramostim Patients receive placebo vaccine and GM-CSF subcutaneously. Arm II placebo Patients receive placebo vaccine and GM-CSF subcutaneously.
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Remission duration Relapse-free survival Immune response as measured by PR1-HLA-A2 tetramer assay
Trial Locations
- Locations (15)
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
UPMC Cancer Centers
🇺🇸Pittsburgh, Pennsylvania, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
St. Francis Hospital Cancer Care Services
🇺🇸Indianapolis, Indiana, United States
Vaccine Company
🇺🇸South San Francisco, California, United States
Rush Cancer Institute at Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Cancer Care Centers of South Texas - Southeast
🇺🇸San Antonio, Texas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States