Trial Information

Assessment of Labile Plasma Iron (LPI) as an Alternative Parameter for Iron Overload in MDS and Primary Myelofibrosis Patients With Iron Overload and Its Correlations With the Classical Iron Overload Parameters.

Approximately 60-80% of patients with myelodysplastic syndromes (MDS) present with
symptomatic anemia and 80-90%, of these, will require red blood cell (RBC) transfusions.
Excess transfusional iron causes iron overload (IO) which is characterized by elevated serum
ferritin (> 1000ng/ml) and transferrin saturation (TSAT > 50%) levels.

Assessment of IO using serum ferritin and TSAT levels is not accurate enough and this is due
to changes in serum ferritin and TSAT during any inflammatory condition.

Since serum ferritin is considered as a positive acute phase reactant and therefore
inflammatory state can lead to an increase in serum ferritin levels and so does not reflect
the exact amount of iron overload.

In contrast TSAT can decrease during inflammation and in addition it follows diurnal
variations.The aim of our present study is to asses the levels of LPI in patients with in
iron overloaded MDS patients (low and high risk), and also patients with primary
myelofibrosis, in order to find out any laboratory correlations between LPI, TSAT and srum
ferritin levels.

Methods:

The study will contain 50 patients low+high risk MDS patients and patients with primary
myelofibrosis with iron overloaded. The risk stratification of these patients will be
calculated according to the WPSS (WHO adapted Prognostic Scoring System)

After ICF (Informed Consent Form) has been signed by the patients the following laboratory
tests will be taken once during the study:

- Ferritin (local laboratory)

- Transferrin Saturation (local laboratory)

- CRP (local laboratory)

- LPI (feROS™ eLPI from Aferrix Ltd., Tel- Aviv, Israel)