At a glance
ClinicalIndex Comparison Record- ✓Adult age ≥18 years
- ✓Diagnosis of MDS by IPSS criteria
- ✓Low or intermediate risk MDS
- ✓Not candidates for growth factor treatment or have failed prior growth factor therapy
- ✕Prior treatment with mycophenolate mofetil or erythropoietin-stimulating agents
- ✕Diagnosis of proliferative chronic myelomonocytic leukemia
- ✕Prior or concurrent malignancies (other than MDS) within 3 years, except basal cell, squamous cell, or adequately treated in situ cervical cancer
- ✕Myelosuppressive or biological antitumor treatment within 28 days before study start
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Study of the Effects of a Combination of NeoRecormon, CellCept and Prednisone on Hematological Parameters and Cytogenesis in Patients With Low or Intermediate Risk Myelodysplastic Syndromes.¿
In Brief
A Phase 2 clinical trial evaluating Mycophenolate mofetil, Prednisone, and 1 other intervention for Myelodysplastic Syndromes. Completed, enrolled 10 participants across 8 sites.
Detailed 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.
Study Details
Timeline
Interventions
1 gm twice daily orally until end of study.
10 mg/day orally until end of study.
Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks.