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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität Dresden
• Collaborator: Dr. Falk Pharma GmbH
• Treatments: Budesonide

Criteria

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