Myelodysplastic Syndromes Clinical Trial
Official title:
Open Label, Multicenter Study to Evaluate Safety/Tolerability and Efficacy of Deferasirox (ICL670) in Myelodysplastic Syndrome Patients With Chronic Transfusional Hemosiderosis.
Open label, single arm study on Deferasirox treatment in MDS patients with chronic
transfusional hemosiderosis.
Patients receive daily oral dosis of Deferasirox in order to eliminate the quantity of iron
administered during transfusions and, if needed, to reduce the overload of already present
iron.
After an screening phase in which patients are evaluated according to eligibility criteria, a
one year treatment phase foresees monthly visits to evaluate safety and efficacy signs.
It has been widely shown that an appropriate chelating therapy in chronic anemias transfusion
dependent can prevent the overstock of iron and can reduce the already existing overstock
reducing, then, the co-morbidity and improving survival.
In particular, some authors have shown in MDS affected patients undergoing intensive
chelating therapy with deferoxamine haematological recovery with a reduction of the need of
transfusions.
With the present study, we plan to evaluate the safety and efficacy of a therapy with the new
oral chelating Deferasirox in MDS patients with transfusional hemosiderosis.
This is an open label, single arm study on Deferasirox treatment in MDS patients with chronic
transfusional hemosiderosis.
Patients will receive daily oral dosis of Deferasirox in order to eliminate the quantity of
iron administered during transfusions and, if needed, to reduce the overload of already
present iron.
After an screening phase in which patients are evaluated according to eligibility criteria, a
one year treatment phase foresees monthly visits to evaluate safety and efficacy signs.
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