NCT00110266

Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients

An Open Label, Safety and Tolerability Study of Deferasirox for Treatment of Transfusional Iron Overload in Low-risk and INT-1, Myelodysplastic Patients Using Serum Ferritin Monitoring

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelodysplastic Syndrome
• Iron Overload

Interventions

Type	Name	Description
DRUG	Deferasirox	20 mg/kg/day over one year in patients with MDS

Timeline

• Start date: 2005-07-25
• Primary completion: 2008-03-28
• Completion: 2008-03-28
• First posted: 2005-05-05
• Last updated: 2021-08-16
• Results posted: 2021-08-16

Locations

48 sites across 2 countries: United States, Canada