drugset / Trial / NCT01868477
Combination Study of Deferasirox and Erythropoietin in Patients With Low- and Int-1-risk Myelodysplastic Syndrome.
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary purpose of this trial was is to assess the effect of treatment with deferasirox combined with erythropoietin vs. erythropoietin alone on erythropoiesis in patients with low- and int-1-risk myelodysplastic syndrome. The addition of deferasirox to erythropoietin can lead to a potential synergism with the reduction of reactive oxygen species, through both the NF-kB pathway and the control of free toxic iron. This may create a better environment in the bone marrow for a better response with erythropoietin. This study was designed to test in a prospective way the combination of deferasirox with erythropoietin in terms of their effect on hematopoiesis.
Timeline
- Start
- 2014-01-28
- Primary completion
- 2017-03-22
- Completion
- 2017-04-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Deferasirox | Unknown | 7 mg/kg | Oral |
| Subject | Deferasirox | Unknown | 10 mg/kg | Oral |
| Subject | Erythropoietin alpha | Protein / enzyme biologic | 40000 iu | — |
| Subject | Erythropoietin alpha | Protein / enzyme biologic | 60000 iu | — |