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

Overview

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.

Full Title of Study: “Efficacy and Safety of Orale Budesonide in the Prevention of Acute Gastrointestinal Graft-versus-host Disease Following Allogenic Stem Cell Transplantation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double
  • Study Primary Completion Date: March 2009

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.

Interventions

  • Drug: Budesonide

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Technische Universität Dresden
  • Collaborator
    • Dr. Falk Pharma GmbH
  • Overall Official(s)
    • Stephan Miehlke, Prof., Principal Investigator, Medical Department I, Technical University Hospital, Dresden, Germany

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