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

This study has been completed.
Sponsor:
Collaborator:
Dr. Falk Pharma GmbH
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00180089
First received: September 9, 2005
Last updated: March 29, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Leukemia
Graft-Versus-Host Disease
Drug: Budesonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Orale Budesonide in the Prevention of Acute Gastrointestinal Graft-versus-host Disease Following Allogenic Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group

Secondary Outcome 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

Estimated Enrollment: 242
Study Start Date: January 2004
Estimated Study Completion Date: January 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • drug or alcohol abuse
  • pregnancy, lactation
  • childbearing potential without effective contraception
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180089

Locations
Germany
Medical Department I, Technical University Hospital
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Dr. Falk Pharma GmbH
Investigators
Principal Investigator: Stephan Miehlke, Prof. Medical Department I, Technical University Hospital, Dresden, Germany
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00180089     History of Changes
Other Study ID Numbers: PROGAST
Study First Received: September 9, 2005
Last Updated: March 29, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
graft-versus-host disease
budesonide
stem cell transplantation

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 16, 2014