Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation

Efficacy and Safety of Orale Budesonide in the Prevention of Acute Gastrointestinal Graft-versus-host Disease Following Allogenic Stem Cell Transplantation

The purpose of this study is to determine whether orale budesonide is effective in the prevention of acute gastrointestinal graft-versus-host disease (GVHD) following allogenic stem cell transplantation.

The purpose of this study is to determine whether orale budesonide is effective in the prevention of acute gastrointestinal graft-versus-host disease (GVHD) following allogenic stem cell transplantation.

Inclusion Criteria:

• planned allogenic stem cell or bone marrow transplantation
• HLA identity (max. 1 mismatch)
• standard GVHD prophylaxis with cyclosporin A or tacrolimus combined with MTX, +/- ATG or Campath1H
• written informed consent

Exclusion Criteria:

• history of allogenic transplantation
• in vitro T-cell depleted transplant
• pretreatment with budesonide within the previous 4 weeks
• known intolerance to budesonide
• gastrointestinal infections
• portal hypertension
• concomitant infectious diseases
• liver cirrhosis, impaired liver function
• severe mental disorder
• lack of compliance
• drug or alcohol abuse
• pregnancy, lactation
• childbearing potential without effective contraception