drugset / Trial / NCT01542684

Study of Azacytidine Followed by GM-CSF in Patients With Myelodysplastic Syndrome (MDS)

NCT01542684 ↗

Phase 2 Terminated 8 enrolled M.D. Anderson Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn if the combination of azacitidine and GM-CSF can help to control MDS. The safety of these drugs will also be studied. Azacitidine is designed to block certain proteins that stop the function of tumor-fighting genes. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better. Granulocyte-macrophage colony-stimulating factor (GM-CSF) is designed to help produce white blood cells. This may help to fight infections.

Timeline

Start
2012-03
Primary completion
2013-04
Completion
2013-04

Outcome

Outcome not reported

Stopped (Enrollment): “Slow Accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacytidine Other / unclassified 40 mg/m2 Intravenous
Subject GM-CSF Protein / enzyme biologic 250 ug/m2 Intravenous

Indications