A Phase 2 interventional study of Alemtuzumab in Autoimmune Cytopenias, sponsored by Phramongkutklao College of Medicine and Hospital. Terminated at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-06-22.
Sponsored by Phramongkutklao College of Medicine and Hospital · Phase 2, Interventional, and Treatment
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.
Phramongkutklao College of Medicine and Hospital is the lead sponsor of 37 studies on the registry; 7 are open to participants now.
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Patients must have a diagnosis of the following autoimmune cytopenias:
immune thromobocytopenia purpura (ITP) autoimmune hemolytic anemia (AIHA) autoimmune neutropenia (AIN) pure red cell aplasia (PRCA) and
Patients must have refractory disease according to the following criteria
Exclusion Criteria:
To investigate the efficacy of alemtuzumab in terms of objective response rate (ORR: complete remission [CR], partial remission [PR]), progression free survival (PFS), and relapse rate in patients with autoimmune cytopenias
To determine the safety profiles of alemtuzumab in patients with autoimmune cytopenias.
This study is terminated, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Alemtuzumab
Phramongkutklao College of Medicine and Hospital