A Phase II Study of Antithymocyte Globulin (ATG) and Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome (MDS)
A growing body of laboratory and clinical evidence suggests that the cytopenia of MDS is at
least partly a result of cytotoxic T cell activity. Treatments to abrogate T cell activity
such as anti-thymocyte globulin alone and cyclosporine alone have demonstrated varying
degrees of success in alleviating the cytopenia of MDS. A response to such therapy in MDS
is associated with improved survival. Experience with aplastic anemia suggests that the
combination of these two agents should be more effective in suppressing cytotoxic T cell
activity and alleviating cytopenia. This protocol proposes using the combination of
antithymocyte globulin (ATG) and cyclosporine (CSA) to treat the cytopenia of MDS, in an
effort to improve the response rate to immunosuppressive therapy in this disease.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Transfusion-independence
6-months
Yes
United States: Federal Government
000169
NCT00005937
June 2000
March 2008
Name | Location |
---|---|
National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |