drugset / Trial / NCT00804050
Multicentric Study Comparison Between Erythropoietin and Erythropoietin Associated to Differentiating Therapy With Acid 13-cis-retinoic and Dihydroxyvitamin D3 in Myelodysplastic Syndromes Without Excess of Blasts
Phase 3
Terminated
184 enrolled
Fondazione Italiana Sindromi Mielodisplastiche-ETS
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, randomized multicenter phase III clinical trial designed to evaluate the safety and activity of comparison between Erythropoietin and Erythropoietin Associated to Differentiating Therapy With Acid 13-Cis-Retinoic and Dihydroxyvitamin D3 in Myelodysplastic Syndromes Without Excess of Blasts
Timeline
- Start
- 2007-03
- Primary completion
- 2009-03
- Completion
- 2010-03
Outcome
Outcome not reported
Stopped (Enrollment): “Difficulties of enrollment”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acid 13-Cis-Retinoic | Unknown | 20 mg | — |
| Subject | Dihydroxyvitamin D3 | Unknown | 1 ug | Oral |
| Subject | epoetin alfa | Protein / enzyme biologic | 40000 iu | — |
| Subject | epoetin alfa | Protein / enzyme biologic | 80000 iu | — |