Evaluation the Effect of Exjade on Oxidative Stress in Low Risk Myelodysplastic Syndrome Patients With Iron Over Load
Recruitment status was Not yet recruiting
Certain percentage of MDS patients develop iron overload. Iron is known to participate in intracellular reactions that generate free radicals, inducing oxidative stress and apoptosis, which was found to be increased in MDS patients and consequently resulted in ineffective hematopoiesis. The aim of this study is to evaluate the antioxidant effect of the oral iron chelator Deferasirox –Exjade in low risk MDS patients with iron over load by evaluating changes in several oxidative stress parameters Certain percentage of MDS patients develop iron overload.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase IV , Multicenter ,Open Label ,Non Comparative ,Investigator Initiated Study , Evaluating the Effect of Exjade on Oxidative Stress in Low Risk Myelodysplastic Syndrome Patients With Iron Over Load|
- To evaluate the antioxidative effect of Exjade therapy in MDS patients
- with iron over load by evaluating oxidative stress parameters
- pre and post treatment
- To evaluate the safety and tolerability of Exjade over the treatment period.
- To analyze iron overload after Exjade treatment period.
- To evaluate transfusion requirements.
- To confirm the value of LPI, LIP, and Hepcidin as a marker for accurate monitoring of chelation therapy in MDS patients with iron over load.
|Study Start Date:||May 2007|
|Estimated Study Completion Date:||August 2008|
|Contact: Rachmilewitz Eliezer, MDfirstname.lastname@example.org|
|Contact: Winder Asher, MD||972 54 email@example.com|
|Study Chair:||Rachmilewitz Eliezer, MD||Wolfson Medical Center|