drugset / Trial / NCT00379912
Azacitidine and Erythropoietin Versus Azacitidine Alone for Patients With Low-Risk Myelodysplastic Syndromes
Phase 2
Terminated
15 enrolled
Larry Cripe, MD
Celgene Corporation · collabOrtho Biotech Clinical Affairs, L.L.C. · collabWalther Cancer Institute · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 50 mg/m2 | Subcutaneous |
| Subject | epoetin alfa | Protein / enzyme biologic | 60000 iu | Subcutaneous |