Conditions: Acute Gastrointestinal Graft vs Host Disease
Keywords: BDP orBec GVHD beclomethasone dipropionate bone marrow transplant hematopoietic cell transplant HCT stem cell transplant marrow transplant SCT beclomethasone 17,21-dipropionate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 140
Healthy volunteers: no

Brief summary:
Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.

Detailed description:

Arms:
arm 1: Investigational drug arm 2: Control

Interventions: intervention 1: oral beclomethasone 17,21-dipropionate intervention 2: Placebo
Intervention descriptions: intervention 1: Two tablets QID for 50 days intervention 2: Two tablets QID for 50 days

Protocol document: