Status:
COMPLETED
Safety, Tolerability, and Efficacy of Deferasirox in MDS
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Myelodysplastic Syndromes
Hemosiderosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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, ...
Eligibility Criteria
Inclusion
- Patients, both males and females, with low and intermediate I risk (IPSS score) Myelodysplastic syndrome and transfusion-induced hemosiderosis.
- Age \>=18 years
- Patients who never received chelation therapy or who received a therapy with Desferal after a day of wash out
- Medical history of at least 20 blood transfusions (equivalent to 100 ml/kg of red cells concentrate).
- Availability of data concerning blood transfusions during the 12 weeks before screening
- Serum ferritin \>= 1000 µg/L at least twice (at least 2 week interval between the 2 analysis) during the year before the screening
- Life expectancy \> 12 months
- Availability of at least 3 complete blood counts (before transfusions) during the 12 weeks before the screening
Exclusion
- Diagnosis different from MDS (i.e. myelofibrosis)
- Severe renal impairment (creatinine clearance \< 60 ml/min)
- ALT/AST \> 500 U/L
- Active B and/or C hepatitis
- Patients treated during the past 4 weeks with experimental drugs for MDS (including thalidomide, azacitidine, arsenic trioxide). These patients become eligible after a "wash out" of at least 4 weeks
- Concomitant treatment with another iron-chelating agent
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00469560
Start Date
June 1 2007
End Date
November 1 2013
Last Update
November 22 2016
Active Locations (17)
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1
SOC EMATOLOGIA ASO SS Antonio e Biagio
Alessandria, Italy
2
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
Bologna, Italy
3
CTMO-Ematologia Ospedale Binaghi
Cagliari, Italy
4
Ospedale "A. Businco"
Cagliari, Italy