High-Dose Cyclophosphamide for the Treatment of Severe Autoimmune Enteropathy
- Determine the rate of treatment-free remission in young patients with severe autoimmune
enteropathy treated with high-dose cyclophosphamide.
- Determine the toxic effects of this drug in these patients.
OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive
filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3
days or until blood counts recover.
After completion of study treatment, patients are followed periodically for up to 1½ years.
PROJECTED ACCRUAL: A total of 7-11 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Treatment-free remission at 1 year after study completion
David M. Loeb, MD, PhD
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|