ASSIST I was the first randomized trial in patients with scleroderma to not just slow disease
progression but rather actually reverse it. It is the first treatment to have ever
demonstrated reversal of lung disease in scleroderma with improvement in FVC, total lung
capacity (TLC), high-resolution computed tomography (HRCT), and QOL. We now, therefore,
purpose to compare the ASSIST I conditioning regimen of cyclophosphamide and rATG to a less
intense regimen of rATG/cyclophosphamide/Fludarabine. In the new regimen the cyclophosphamide
dose is decreased to 120mg/kg (60mg/kg/day x 2) compared to 200mg/kg (50mg/kg/day) in the
standard regimen. The lower dose of cyclophosphamide will be less cardiotoxic. This study
will determine if the less cardiotoxic regimen will be safer than the standard regimen and as
effective as the standard regimen.