drugset / Trial / NCT01065129

Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) in Combination With Azacitidine for the Treatment of Myelodysplastic Syndrome (MDS)

NCT01065129

Phase 1 Completed 28 enrolled Washington University School of Medicine
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Our main objectives are to determine the optimal dose and schedule of plerixafor + G-CSF and azacitidine in patients with MDS and determine the safety and tolerability of plerixafor + G-CSF and azacitidine.

Timeline

Start
2010-09-02
Primary completion
2014-07
Completion
2016-10-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 75 mg/m2 Subcutaneous
Subject Plerixafor Small molecule 320 ug/kg Subcutaneous
Subject Plerixafor Small molecule 440 ug/kg Subcutaneous
Subject Plerixafor Small molecule 560 ug/kg Subcutaneous
Subject filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous