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Completed

NCT Number: NCT00180089

Budesonide for Prevention of Acute Gastrointestinal GVHD 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.

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Key information

Conditions

Leukemia Graft vs Host Disease Graft-Versus-Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Neoplasms Neoplasms by Histologic Type

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Department I, Technical University Hospital

Dresden, 01307, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide

Drug

Primary outcomes

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

Secondary outcomes

  1. safety

  2. grade of acute GI GVHD

  3. incidence of chronic GI GVHD

  4. incidence of infectious complications

  5. overall and disease-free survival 1 yr after transplant

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • Dr. Falk Pharma GmbH

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2010
First posted
Sep 16, 2005
Registry last updated
Mar 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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