Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454168
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2007-03-27
Brief Title:
Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in Remission
Sponsor:
The Vaccine Company
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VACCINE-PR1-104 | None | None | None |
| UCCRC-14613B | None | None | None |