Conditions: Myelodysplastic Syndrome Iron Overload
Keywords: ICL670 Deferasirox Iron chelation Chelator Desferal
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 176
Healthy volunteers: no

Brief summary:
The purpose of this trial is to examine the safety and efficacy of deferasirox in patients with Myelodysplastic Syndrome (MDS) and chronic iron overload from blood transfusions.

Detailed description:
Study entry requires a diagnosis of low or intermediate (INT-1) risk MDS per International Prognostic Scoring System (IPSS) criteria and serum ferritin ≥ 1000 ng/mL. Patients must have had at least 30 prior red blood cell transfusions. Deferasirox will be administered at an initial dose of 20 mg/kg orally once per day. Patient transfusion history and at least three complete blood count (CBC) values must be available for the 12 weeks prior to study registration for patients with MDS and chronic iron overload from blood transfusions.

Arms:
arm 1: Evaluate the safety and tolerability of deferasirox 20 mg/kg/day over one year in patients with MDS

Interventions: intervention 1: Deferasirox
Intervention descriptions: intervention 1: 20 mg/kg/day over one year in patients with MDS

Protocol document: