Randomized Study of Oral Beclomethasone Dipropionate With Ten Days of Prednisone for Treatment of Gastrointestinal GVHD
Status:
Completed
Trial end date:
2004-12-01
Target enrollment:
Participant gender:
Summary
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.