Low and Int 1-risk Myelodysplastic Syndrome Clinical Trial
Official title:
An Open-label, Phase II, Randomized, Pilot Study to Assess the Effect in Term of Erythroid Improvement of Deferasirox Combined With Erythropoietin Compared to Erythropoietin Alone in Patients With low-and Int-1-risk Myelodysplastic Syndrome.
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.
This study did not meet the original enrollment objective of 60 patients and was terminated without extending enrollment past original planned LPFV of 31-Oct-2016. ;