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Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in Remission

NCT00454168 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2014-01-06

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

PR1 leukemia peptide vaccine

Given subcutaneously

BIOLOGICAL

sargramostim

Given subcutaneously

OTHER

placebo

Given subcutaneously

Sponsors & Collaborators

  • The Vaccine Company

    lead INDUSTRY

Principal Investigators

  • Craig S. Rosenfeld, MD · The Vaccine Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2009-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00454168 on ClinicalTrials.gov