Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome
Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes
Eligibility Criteria
Hypoplastic MDS, or MDS subtype RA, RAS or RAEB with ≤ 10% blasts, or RAEB with 10-20% blasts and the patient refusing or not eligible for the MDS high risk protocol (EORTC 06961) Transfusion dependence < 24 months or neutrophils < 0.5 × 109/l. ECOG/SAKK performance status ≤ 2 Age > 18 years No active uncontrolled infection No prior chemotherapy or radiotherapy No history of heart failure, clinically relevant cardiac arrhythmia or other hemato-oncological disease
Sites / Locations
- Universitaetsspital-Basel
Arms of the Study
Arm 1
Arm 2
Active Comparator
Other
Arm A: ATG + CSA
Arm B: Supportive care
Treatment consists of 15 mg/kg ATG (Mérieux; horse antithymocyte globulin; i.e. 1.5 vial/10 kg of body weight/day) given over 8-12 hours for 5 consecutive days. Cyclosporine A (CSA) will be administered orally in a dose of 2.5 mg/kg bid starting day 1 and continued through day 180.
Patients randomized to this arm will be treated as outpatients.