drugset / Trial / NCT01868477

Combination Study of Deferasirox and Erythropoietin in Patients With Low- and Int-1-risk Myelodysplastic Syndrome.

NCT01868477 ↗

Phase 2 Completed 28 enrolled Novartis Pharmaceuticals
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

Outcome

Missed primary endpoint

registry Mean Difference (Final Values) 14.4 (95% CI -24.0 to 48.16) NCT01868477 ↗

Drugs

EvaluationDrugModalityDoseRoute
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 —