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The Effect of Treatment With the Oral Iron Chelator Deferiprone on the Oxidative Stress of Blood Cells and on Iron Overload Status in Transfusion Dependent, Iron-overloaded Patients With Low Risk Myelodysplastic Syndrome
In Brief
A Phase 2 clinical trial evaluating Deferiprone for Myelodysplastic Syndrome With Low-grade Lesions and Iron Overload Due to Repeated Red Blood Cell Transfusions. Completed, enrolled 19 participants across 1 site.
Detailed Summary
The effect oral iron chelator Deferiprone on the Oxidative stress and on Iron Overload status in transfusion dependent, iron-overloaded low risk MDS patients; Primary Objective: • To evaluate the effect of Deferiprone on oxidative stress parameter - Reactive oxygen species (ROS). Secondary Objectives: * To evaluate the effect of Deferiprone on other oxidative stress parameters 1. Reduced glutathione 2. Membrane lipid peroxidation 3. External phosphatidylserine * To evaluate the change from baseline to last visit in parameters of iron load. 1. Serum ferritin (despite ongoing RBC transfusions during the study period). 2. LIP 3. LPI 4. serum hepcidin * To evaluate the change from one month preceding baseline visit to last month on study in transfusion requirements. * To monitor safety measures: 1. Adverse events (AEs). 2. Number of discontinuations due to AEs Study design: Single-arm, open-label, multi-center study in 20 iron-overloaded patients with low risk MDS. All participants will be treated with deferiprone for up to 4 months. Patients will have complete blood count monitored weekly, and will visit the site monthly for assessments of safety and efficacy.
Study Details
Timeline
Interventions
This is a single-arm, open-label, multi-center study in 20 patients with MDS. All participants will be treated with deferiprone for up to 4 months.