NCT00004208

Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	ATG + CSA	Mérieux; horse antithymocyte globulin (ATG) + Cyclosporine A (CSA)
BEHAVIORAL	Supportive care	Patients randomized to this arm will be treated as outpatients.

Timeline

• Start date: 2000-08-01
• Primary completion: 2006-10-01
• Completion: 2011-10-01
• First posted: 2003-01-27
• Last updated: 2015-03-11

Locations

1 site across 1 country: Switzerland