drugset / Trial / NCT00379912

Azacitidine and Erythropoietin Versus Azacitidine Alone for Patients With Low-Risk Myelodysplastic Syndromes

NCT00379912

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is designed to explore a modified dose and schedule of azacitidine in order to more effectively address the needs of patients with low-risk myelodysplastic syndromes (MDS), i.e., to alter the natural history of the disease without excessive toxicity or burden. The administration of erythropoietin is designed to influence the differentiation of primitive hematopoietic cells in which azacitidine has reversed the abnormal phenotype to red blood cells for patients in whom inadequate production of red blood cells is the major clinical issue.

Timeline

Start
2006-09
Primary completion
2008-12
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 50 mg/m2 Subcutaneous
Subject epoetin alfa Protein / enzyme biologic 60000 iu Subcutaneous