drugset / Trial / NCT00551291
A Study of NeoRecormon (Epoetin Beta), CellCept (Mycophenolate Mofetil) and Prednisone in Patients With Low or Intermediate Myelodysplastic Syndromes.
NaSingle-groupOpen-labelTreatment
Summary
This single arm study will evaluate the efficacy and safety of a combination of NeoRecormon, CellCept and prednisone in patients with low or moderate risk myelodysplastic syndromes (MDS). In the first phase of the study, patients will receive CellCept (1g p.o. twice daily) plus prednisone. After 3 months, if patients have not responded to treatment, NeoRecormon (30000 IU/week, s.c.) will be added to the treatment regimen. If there is no response to NeoRecormon after 6 weeks, the dose will be increased to 60000 IU/week. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Timeline
- Start
- 2007-08
- Primary completion
- 2009-06
- Completion
- 2009-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erythropoietin Beta | Protein / enzyme biologic | 30000 iu | Subcutaneous |
| Subject | Mycophenolate Mofetil | Small molecule | 1 g | Oral |
| Subject | Prednisone | Other / unclassified | 10 mg | Oral |