Conditions: Myelodysplastic Syndromes
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 10
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.

Interventions: intervention 1: Mycophenolate mofetil intervention 2: Prednisone intervention 3: Erythropoietin Beta
Intervention descriptions: intervention 1: 1 gm twice daily orally until end of study. intervention 2: 10 mg/day orally until end of study. intervention 3: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks.

Protocol document: