Combination Study of Deferasirox and Erythropoietin in Patients With Low- and Int-1-risk Myelodysplastic Syndrome.
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
Outcome
Missed primary endpoint
registry Mean Difference (Final Values) 14.4 (95% CI -24.0 to 48.16) NCT01868477 ↗
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 | — |