High-dose Cyclophosphamide for Severe Refractory Crohn Disease

Exclusion Criteria

• •Pregnant or nursing women
• •Sexually active men and women who do not agree to use effective means of birth control during treatment period
• •Evidence of primarily fibrostenosing disease without active inflammatory disease on disease staging
• •Co-morbid conditions including cardiac disease with an ejection fraction of \< 45%, chronic renal failure with serum creatinine \> 2.0, liver disease with total bilirubin \> 2.0, (excluding hyperbilirubinemia secondary to Gilbert's disease) or transaminitis \> 3x upper limit of normal.
• •History of serious allergic reaction to cyclophosphamide
• •History of malignancy in the last 5 years (excluding non-melanomatous skin cancers)
• •Patients who are pre-terminal
• •Toxic megacolon
• •Active infection
• •White blood cell count \< 3000 cells/ul, platelets \< 100K / ul, hemoglobin \< 10.0 g/dL
• •Any use of thiopurines, methotrexate or anti-TNF agents in the previous four weeks prior to treatment