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Clinical Trials/NCT00180089
NCT00180089
Completed
Phase 3

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

Technische Universität Dresden1 site in 1 country242 target enrollmentJanuary 2004
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ConditionsLeukemiaGraft-Versus-Host Disease
DrugsBudesonide

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Leukemia
Sponsor
Technische Universität Dresden
Enrollment
242
Locations
1
Primary Endpoint
incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2004
End Date
January 2010
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group

Secondary Outcomes

  • incidence of infectious complications
  • grade of acute GI GVHD
  • safety
  • overall and disease-free survival 1 yr after transplant
  • incidence of chronic GI GVHD

Study Sites (1)

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