Cytoxan ® (cyclophosphamide) and Revimmune for Systemic Scleroderma
Cytoxan for Systemic Scleroderma Lung Disease, Pulmonary Fibrosis, Alveolitis, and Skin Fibrosis
| SCOT Clinical Trial SCOT Substudy 01 Northwestern University Clinical Trials |
Scleroderma Lung Study II Cyclophosphamide Research Also see |
SCOT Clinical Trial: Open Enrollment, 2005-2008
SCOT Clinical Trial, which stands for "Scleroderma Cyclophosphamide Or Transplantation", will compare two potential therapies: autologous stem cell transplantation versus high-dose monthly cyclophosphamide. Study dates 2005-2016. (Also see Scleroderma Clinical Trials: Current and Stem Cell Transplantation)
SCOT Substudy 01 Clinical Trial (By invitation only)
Scleroderma: Cyclophosphamide or Transplantation (SCOT) Substudy 01. The primary purpose of this study is to determine the plasma concentration and exposure time required for cyclosphosphamide to produce optimal immunosuppressive activity with minimal toxicity in subjects with severe systemic sclerosis. This study is currently enrolling participants by invitation only. ClinicalTrials.gov. 02/19/09.
Northwestern University Clinical Trials
Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic Sclerosis. This study is designed to examine whether treating patients with high dose Cyclophosphamide and Fludarabine (drugs which reduce the function of your immune system) and CAMPATH-1H (a protein that kills the immune cells that are thought to be causing the disease), followed by return of blood stem cells that have been previously collected from patients brother or sister will stop or reverse the disease. This study is currently recruiting participants. (Northwestern) ClinicalTrials.gov.
Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic Scleroderma. To evaluate the efficacy (phase II) of two treatment modalities: pulse cyclophosphamide versus high dose cyclophosphamide and rATG rescued with autologous peripheral blood stem cell transplantation. This study is currently recruiting participants. (Northwestern). ClinicalTrials.gov. Contact information: d-spahovic@northwestern.edu and tel 1-312-908-0059.
Scleroderma Lung Study I: Postitive Results with Oral Cyclophosphamide
Systemic sclerosis (SSc) sera affect fibrillin-1 deposition by dermal blood microvascular endothelial cells: therapeutic implications of cyclophosphamide (CYC). In SSc, CYC treatment might limit fibrosis through the maintenance of physiological fibrillin–1 synthesis and deposition by B–MVECs. PubMed, Arthritis Res Ther, 2013 Aug 20.
Results from the Scleroderma Lung Study I. This study showed that 1 year of oral cyclophosphamide (CYC) was effective in improving lung function, symptoms of shortness of breath, and quality of life but the effect on lung function and quality of life only lasted for another 6 months after CYC was stopped. UCLA.
Correlation of Cough With Disease Activity and Treatment With Cyclophosphamide in Scleroderma Interstitial Lung Disease (SSc-ILD). Findings from the Scleroderma Lung Study. Cough is a common symptom in SSc-ILD and correlates with the extent of fibrosis. It may be a symptom of ongoing fibrosis. CHEST Journal, Vol 142, No 3, September 2012. (Also see Lung Involvement and Pulmonary Fibrosis Treatments)
Adverse Effects of Scleroderma Lung Study. Over 2 years, cyclophosphamide was associated with more adverse events (AEs) than placebo, including overall AEs and relative leukopenia. There were no differences in other AEs, including serious AEs, cancers, or deaths. (PubMed) Furst DE. Am J Med, 2011 May;124(5):459-67.
Scleroderma Lung Study II
Scleroderma Lung Study II. This study compares 2 different medications—daily oral cyclophosphamide (CYC, also called Cytoxan™) with daily oral mycophenolate mofetil (MMF, also called Cellcept™) in the treatment of scleroderma-related pulmonary fibrosis. There are twelve study centers across the U.S. This study is currently recruiting. University of California, Los Angeles. November 2009. (Also see Pulmonary Fibrosis, Cellcept, Cytoxan, and Clinical Trials)
Cyclophosphamide Research for Systemic Sclerosis (Scleroderma)
Low-dose pulse cyclophosphamide (CYC) in interstitial lung disease associated with systemic sclerosis (SSc-ILD): Efficacy of maintenance immunosuppression in responders and non-responders. The study supports the use of low-dose pulse CYC as induction therapy of recently deteriorated SSc-ILD. Moreover, it suggests that azathioprine should be administered to CYC-responsive patients but does not show any definite effect of micophenolic acid in unresponsive patients. ScienceDirect, 09/08/2014.
Autologous Hematopoietic Stem Cell Transplantation (HSCT) vs Intravenous Pulse Cyclophosphamide in Diffuse Cutaneous Systemic Sclerosis: A Randomized Clinical Trial. Among patients with early diffuse cutaneous systemic sclerosis, HSCT was associated with increased treatment-related mortality in the first year after treatment. However, HCST conferred a significant long-term event-free survival benefit. JAMA, 2014;311(24):2490-2498. (Also see Stem Cell Transplantation)
Effects of cyclophosphamide on pulmonary function in patients with scleroderma and interstitial lung disease: a systematic review and a meta-analysis of randomized controlled trials and observational prospective cohort studies. Cyclophosphamide treatment in patients with systemic sclerosis related interstitial lung disease does not result in clinically significant improvement of pulmonary function. (UnBound) C. Nannini. Arthritis Res Ther 2008 Oct 20; 10(5):R124. (Also see Pulmonary Fibrosis)
Also See
Pulmonary Fibrosis. ISN.
Scleroderma Medical News. ISN.
Systemic Scleroderma Symptoms (Main list; treatments are listed on each symptom page.) ISN.
Scleroderma Treatments and Clinical Trials. ISN.
Skin Fibrosis. ISN.
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