Evaluating the efficacy of Exjade® (deferasirox) in transfusion dependent chronic anaemias ( Myelodysplasia Syndrome, Beta-thalassaemia major patients) with chronic iron overload

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•In- or outpatients with myelodysplasia / with risk of low or intermedier-1 according to the International Prognostic Scoring System (IPSS) confirmed by bone marrow evaluation within 3 month/ or beta thalassaemia major patients, who have chronic iron overload, as a consequence of frequent blood transfusion
•Serum ferritin> 1800 µg/L
• Age: 18-80 years
•Chronic iron overload caused by at least 30 units and maximum 100 units of blood
of packed red blood cells
•Deferoxamin (Desferal®) therapy is contraindicated or inadequate or unable to use in the recommended dose due to intolerability or other reason
•ECOG performance status score between 0-2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•beta thalassaemia minor,
•haemosiderosis caused by other than chronic transfusional iron overload,
•patients with impaired renal function (Creatinin clearance< 60 ml/ min),
•pregnancy,
•lactation,
•patient of childbearing potencial unwilling to use contraceptive precautions
•known hypersensitivity to Exjade or any ingredients,
•impaired hepatic function (SGOT,SGPT 5x above UNL).
•Patients severely ill due to underlying disease progression or other severe concomitant disease.
•Patients participated in other clinical trial 30 days prior enrollment.
•Patients with poor prognosis of karyotype according to the IPSS
•ECOG performance status score above 2
•patients with malabsorption caused by inflammatory bowel disease, gastrectomy, pancreatitis or other medical condition
•History of nephrotic syndrome
•Significant proteinuria as indicated by a urinary protein/creatinine ratio > 0.5 (mg/mg) in second-voiding urine samples taken at either visits 1 or 2.
•History of non-compliance to medical regimens
•Patients with positive test to HIV
• Life expectancy of < 1year