Status:
COMPLETED
Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation
Lead Sponsor:
Technische Universität Dresden
Collaborating Sponsors:
Dr. Falk Pharma GmbH
Conditions:
Leukemia
Graft-Versus-Host Disease
Eligibility:
All Genders
12-65 years
Phase:
PHASE3
Brief 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 transplantati...
Detailed Description
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 transplantati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT00180089
Start Date
January 1 2004
End Date
January 1 2010
Last Update
March 30 2010
Active Locations (1)
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1
Medical Department I, Technical University Hospital
Dresden, Germany, 01307