At a glance
ClinicalIndex Comparison Record- ✓Low or intermediate-1 (INT-1) risk MDS per IPSS criteria with transfusional iron overload
- ✓Serum ferritin ≥1000 µg/mL at screening (obtained in absence of concomitant infection)
- ✓Minimum 20 prior packed red cell transfusions
- ✓Age ≥18 years
- ✕Serum creatinine >2× upper limit of normal (ULN)
- ✕ALT or AST >5× ULN
- ✕Active hepatitis B or hepatitis C (HBsAg without HBsAb OR HCV Ab positive with HCV RNA positive and elevated ALT)
- ✕Significant proteinuria (urinary protein/creatinine ratio >0.5 mg/mg)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label, Safety and Tolerability Study of Deferasirox for Treatment of Transfusional Iron Overload in Low-Risk and INT-1 Myelodysplastic Patients
In Brief
A Phase 4 clinical trial evaluating Deferasirox for Myelodysplastic Syndromes and Iron Overload. Completed, enrolled 24 participants across 3 sites.
Detailed Summary
Thirty patients were to be enrolled and 24 patients were actually enrolled into this open-label, single-arm trial designed to assess the safety and tolerability of oral deferasirox in adult transfusion dependent myelodysplastic syndrome (MDS) patients with iron overload. Patients enrolled in this study had low or intermediate (INT-1) risk MDS per International Prognostic Scoring System (IPSS) criteria. All patients initiated treatment with 20mg/kg/day deferasirox. Deferasirox were administered orally once per day for 12 months.