drugset / Trial / NCT00454168

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

NCT00454168

Phase 3 Unknown 244 enrolled The Vaccine Company
RandomizedTreatment

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.

Timeline

Start
2005-05
Primary completion
2009-04
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject PR1 leukemia peptide vaccine Vaccine Subcutaneous
Background sargramostim Protein / enzyme biologic Subcutaneous

Indications