Trial Information

Summary: A Randomized, Open-Label, Phase II/III Multicenter Study of High Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM and Autologous Transplantation with Auto CD34+ HPC Versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis

You have been asked to participate in this research study because you have severe systemic sclerosis (SSc), also known as scleroderma.  The main purpose of this study is to determine the safety and effectiveness of high-dose immunosuppressive therapy followed by reinfusion (transplantation) of autologous (collected from the subject) peripheral blood stem cells (PBSCs, immature cells that can become blood cells) compared to treatment with monthly (for 12 months) intravenous doses of cyclophosphamide (Cytoxan, CTX) therapy for the treatment of SSc.  These two treatments will be compared in regard to effectiveness at slowing down or stopping SSc from becoming more severe and possibly reversing the effects of the disease.  An additional purpose is to evaluate the effects on survival related to SSc, serious organ damage and side effects related to the two treatments.  Your participation in this study is expected to last approximately two months for screening, up to 12 months for treatment, depending upon which treatment you are assigned.  From the time that treatment is started, each subject will be followed in this study for up to 5 years.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: July 7, 2008 at 2:31:14 PM