Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00469560
Status:
COMPLETED
Last Update Posted:
2016-11-22
First Post:
2007-05-03
Brief Title:
Safety Tolerability and Efficacy of Deferasirox in MDS
Sponsor:
Gruppo Italiano Malattie EMatologiche dellAdulto
Organization:
Gruppo Italiano Malattie EMatologiche dellAdulto
Study Overview
Official Title:
Open Label Multicenter Study to Evaluate SafetyTolerability and Efficacy of Deferasirox ICL670 in Myelodysplastic Syndrome Patients With Chronic Transfusional Hemosiderosis
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None