High-dose Cyclophosphamide for Severe Refractory Crohn Disease
Status:
Withdrawn
Trial end date:
2018-03-01
Target enrollment:
Participant gender:
Summary
This research is being done to see if people with Crohn's disease who receive high-dose
cyclophosphamide have an improvement of their disease, how long the benefit may last, and how
safe cyclophosphamide is. This study is for patient with medically refractory disease that is
not easily amenable to surgery.
Cyclophosphamide is an FDA-approved chemotherapy medication that is also frequently used to
treat autoimmune illness; use of cyclophosphamide for autoimmune disease is not approved by
the FDA. An autoimmune illness is when the immune system mistakenly attacks self, targeting
the cells, tissues, and organs of a person's own body. There are many different autoimmune
diseases and they can each affect the body is different ways. Crohn's disease is an
autoimmune disease that primarily affects the small and large intestines. High
dose-cyclophosphamide has been successfully used to treat Crohn's, primarily as part of a
conditioning regimen for autologous stem cell transplantation. However, this therapy is
limited in Crohn's because of it's serious infectious risks. This current study involves
using high-dose cyclophosphamide without need for stem cell transplantation. This appears to
be a safer approach in other autoimmune illnesses that have been studied.