*CLOSED TO RECRUITMENT*
- SUB-TYPE OF MDS: All.
- SEVERITY OF MDS: Low to Intermediate 1
- NAME OF DRUG: Deferasirox and Erythropoietin (EPO)
- Aims and benefits: This trial will assess the impact on hemoglobin, platelets and neutrophil, and iron levels in patients treated with Deferasirox combined with Erythropoietin (compared to Erythropoietin alone)
- Main basic inclusion criteria:
- Myelodysplastic syndrome lasting = 3 months and < 3 years
- Disease must not be secondary to treatment with radiotherapy, chemotherapy, and/or immunotherapy for malignant or autoimmune diseases
- A hemoglobin < 10 g/dL and = 8 g/dL
- History of transfusions < 10 RBC units and must not be RBC transfusion dependent
- 300 ng/mL < serum ferritin < 1,500 ng/mL (Values within 10% difference above 1500 ng/ml or 10% difference below 300 ng/ml may be accepted at the investigator’s discretion.
- Endogenous erythropoietin levels < 500 units/L
- Main basic exclusion criteria:
- Patients with MDS with isolated del(5q)
- Patients who had received prior EPO treatment or other recombinant growth factors regardless of the outcome (Patient who had received prior EPO treatment or other recombinant growth factors for less than 4 weeks and not within 3 months before screening without a documented response are allowed)
- Patients receiving steroids or immunosuppressive therapy for the improvement of hematological parameters (stable steroid treatment for adrenal failure or chronic medical conditions, and intermittent dexamethasone as antiemetics are allowed).
- Trial sites/locations and name of physician in charge of trial: Novartis Investigative Site Active, not recruiting, Oldham, Lancashire, United Kingdom, OL1 2JH
Novartis Investigative Site, Recruiting, London, United Kingdom, WC1E 6HX
- More information: https://clinicaltrials.gov/ct2/show/NCT01868477
Please read information and always discuss trial information with your own physician.