Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this trial is to evaluate the efficacy and toxicity of intensive immuno-suppression with ATG + CSA versus best supportive care in patients with transfusion dependent low and intermediate risk myelodysplastic syndrome (MDS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Antilymphocyte Serum; Cyclosporine; Cyclosporins

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