drugset / Trial / NCT00363649

Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI

NCT00363649

RandomizedCrossoverOpen-labelTreatment

Summary

RATIONALE: Tyrosine kinase inhibitors may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Interferon alfa may interfere with the growth of cancer cells. GM-CSF may help cells that are involved in the body's immune response work better. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells. PURPOSE: This randomized phase II trial is studying tyrosine kinase inhibitors, interferon alfa, and GM-CSF to see how well they work compared to tyrosine kinase inhibitors and vaccine therapy in treating patients with chronic phase chronic myelogenous leukemia.

Timeline

Start
2006-09
Primary completion
2017-09
Completion
2017-09

Drugs

EvaluationDrugModalityDoseRoute
Subject GM-K562 cell vaccine Vaccine Other
Subject interferon alfa Protein / enzyme biologic Other
Subject sargramostim Protein / enzyme biologic Other

Indications