Randomized Study of Oral Beclomethasone Dipropionate With Ten Days of Prednisone for Treatment of Gastrointestinal GVHD
Patients with gastrointestinal graft-vs.-host disease are randomized to oral beclomethasone dipropionate (BDP) 8 mg/day or identical placebo tablets for 50 days, along with a 10-day induction course of prednisone. At study day 10, patients whose symptoms of GVHD are under control undergo a rapid prednisone taper over 7 days, while study drug is continued to study day 50. After discontinuation of study drug at study day 50, patients are followed for 30 additional days, to study day 80. The primary endpoint is treatment failure by day 50, that is, a flare of the symptoms of GVHD that requires immunosuppressive therapy. Secondary endpoints are treatment failure by day 80, treatment-emergent adverse events, and survival at transplant day 200. The hypothesis to be tested is that a topically-active corticosteroid (beclomethasone dipropionate, BDP), taken orally, would allow rapid tapering of prednisone while maintaining control of intestinal GVHD.
Graft Vs Host Disease
Gastrointestinal Graft-Versus-Host Disease
Drug: Oral beclomethasone dipropionate (drug)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Placebo-Controlled, Multi-Center Study of Oral Beclomethasone Dipropionate With Ten Days of Prednisone for Treatment of Gastrointestinal Graft Vs. Host Disease|
- Treatment failure (that is, flares of GVHD requiring immunosuppressive drug therapy) at study day 50.
- Treatment failure at study day 80.
- Survival at transplant day 200.
- Adverse events.
|Study Start Date:||July 2001|
|Estimated Study Completion Date:||December 2004|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Study Director:||Timothy C. Rodell, M.D.||Enteron Pharmaceuticals, Inc., a subsidiary of DOR BioPharma|
|Study Director:||Scott Cruickshank, Ph.D.||Enteron Pharmaceuticals Inc, a subsidiary of DOR BioPharma|