Spots Global Cancer Trial Database for Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome

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Trial Identification

Brief Title: Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome

Official Title: Antithymocyte Globulin (ATG) and Cyclosporine (CSA) to Treat Patients With Myelodysplastic Syndrome (MDS). A Randomized Trial Comparing ATG + CSA With Best Supportive Care

Study ID: NCT00004208

Conditions

Myelodysplastic Syndromes

Interventions

ATG + CSA

Supportive care

Study Description

Brief 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).

Detailed Description: This trial will answer the question whether immuno-suppression improves hematopoesis and reduces transfusion requirements analogous to patients with aplastic anemia as the short-term outcome, and whether immuno-suppression accelerates leukemic transformation and influences survival as the long-term outcome. Primary endpoint: best response (CR + PR) rate at month 6