Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in Remission
Public ClinicalTrials.gov record NCT00454168. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00454168
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 244 participants
Conditions and interventions
Conditions
Interventions
- PR1 leukemia peptide vaccine Biological
- sargramostim Biological
- placebo Other
Biological · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2005 (Type not available)
- Primary completion
- Apr 2009 (Estimated)
- Completion
- Not listed
- Last update posted
- Jan 6, 2014
Started 2005
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259-5499 | — |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | — |
| Vaccine Company | South San Francisco | California | 94080 | — |
| Rush Cancer Institute at Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | — |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202-5289 | — |
| St. Francis Hospital Cancer Care Services | Indianapolis | Indiana | 46237 | — |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | 66160-7357 | — |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | — |
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | — |
| UPMC Cancer Centers | Pittsburgh | Pennsylvania | 15232 | — |
| 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 | — |
| Cancer Care Centers of South Texas - Southeast | San Antonio | Texas | 78222 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00454168, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 6, 2014 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00454168 live on ClinicalTrials.gov.