Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation
Phase 3
Completed
- Conditions
- LeukemiaGraft-Versus-Host Disease
- Registration Number
- NCT00180089
- Lead Sponsor
- Technische Universität Dresden
- 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 transplantation.
- 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 transplantation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 242
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group
- Secondary Outcome Measures
Name Time Method grade of acute GI GVHD safety incidence of chronic GI GVHD incidence of infectious complications overall and disease-free survival 1 yr after transplant
Trial Locations
- Locations (1)
Medical Department I, Technical University Hospital
🇩🇪Dresden, Germany