The Efficacy and Safety of Alemtuzumab in Auotoimmune Cytopenias
Status:
Terminated
Trial end date:
2009-05-01
Target enrollment:
Participant gender:
Summary
The majority of cases of autoimmune cytopenias, which includes immune thrombocytopenia (ITP),
autoimmune hemolytic anemia, autoimmune neutropenia (AIN) and pure red cell aplasia, will
respond to conventional immunosuppressive therapy with or without splenectomy. There is,
however, a group of patients with refractory or chronically relapsing autoimmune cytopenias
causing life-threatening hemorrhages, infections or anemia. Further problems include the
short- and long-term side-effects of corticosteroids, and the potential toxicity of
immunosuppressive and cytotoxic agents. An alternative and less toxic approach in these
patients may be the treatment with Campath-1H, a humanized IgG monoclonal antibody specific
for the CD52 antigen and present on human lymphocytes and monocytes. The main effect of
Campath-1H is on T cell and it results in a prolonged and profound depletion of the CD4 and
CD8 subpopulations, particularly the CD4 population, and this might "reset" the immune system
without the need for total immune ablation.Therefore, this study is designed to investigate
safety and efficacy of repeated Campath treatment cycles in autoimmune cytopenia.In order to
minimize possible side effects of accumulating Campath, the 3 treatment cycles will be
administered in consecutively reduced doses.