Clinical Trials. gov identifier:
N° of patients expected by the study:
> 18 years old
Myelodysplasia object of the study:
Low-risk myelodysplastic syndrome
Multicentric phase II study
Title of the study:
Low doses of Deferasirox (3.5 mg / kg FCT) administered early to suppress basic iron (NTBI and LPI) as an early intervention to prevent tissue iron overload in low-risk MDS.
Description of the study:
Myelodysplastic syndromes are a group of hematologic malignancies that involve hematopoietic stem cells and express themselves clinically with different degrees of cytopenias. to a high transfusion requirement.
One of the inevitable consequences of this is iron overload, which has been shown to be detrimental. The prevention of tissue and organ damage due to iron overload often makes it necessary to introduce an iron chelation drug into MDS therapy.
The iron chelation therapy with Deferasirox is approved for patients with MDS and its benefits have been demonstrated in many studies. , is well tolerated, able to prevent the accumulation of iron and, consequently, the damage from accumulation.
For this purpose toxic iron will be evaluated by tests on peripheral blood and MRI T2 *. This is a multicenter phase II study; the promoter of the study is FISiM.
The study foresees the sending of biological samples to centralized laboratories throughout the duration of the protocol.