Efficacy and Safety of Orale Budesonide in the Prevention of Acute Gastrointestinal Graft-versus-host Disease Following Allogenic Stem Cell Transplantation
12 Years
65 Years
Both
Leukemia, Graft-Versus-Host Disease
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Outcome Measure:
incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group
Principal Investigator
Stephan Miehlke, Prof.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical Department I, Technical University Hospital, Dresden, Germany
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
PROGAST
NCT ID:
NCT00180089
Start Date:
January 2004
Completion Date:
January 2010
Related Keywords:
- Leukemia
- Graft-Versus-Host Disease
- graft-versus-host disease
- budesonide
- stem cell transplantation
- Graft vs Host Disease
- Leukemia
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