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

This study is currently recruiting participants.

Verified by Dresden University of Technology, June 2005

First Received: September 9, 2005 Last Updated: February 12, 2007 History of Changes

Sponsor:	Dresden University of Technology
Collaborator:	Dr. Falk Pharma GmbH
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00180089

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

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:	August 2005

Detailed Description:

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

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

Contacts

Contact: Stephan Miehlke, Prof.	+49 351 458 ext 5645	stephan.miehlke@uniklinikum-dresden.de
Contact: Martin Bornhäuser, Prof.	+49 351 458 ext 4190	martin.bornhaeuser@uniklinikum-dresden.de

Locations

Germany
Medical Department I, Technical University Hospital	Recruiting
Dresden, Germany, 01307
Contact: Martin Bornhäuser, Prof. +49 351 458 ext 4190 martin.bornhaeuser@uniklinikum-dresden.de
Contact: Stephan Miehlke, Prof. +49 351 458 ext 5645 stephan.miehlke@uniklinikum-dresden.de
Principal Investigator: Martin BornhäuserpROF:

Sponsors and Collaborators

Dresden University of Technology

Dr. Falk Pharma GmbH

Investigators

Principal Investigator:

Stephan Miehlke, Prof.

Medical Department I, Technical University Hospital, Dresden, Germany

More Information

No publications provided

Study ID Numbers:	PROGAST
Study First Received:	September 9, 2005
Last Updated:	February 12, 2007
ClinicalTrials.gov Identifier:	NCT00180089 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

graft-versus-host disease
budesonide
stem cell transplantation

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Hormones

Glucocorticoids
Pharmacologic Actions
Leukemia
Neoplasms
Autonomic Agents
Therapeutic Uses
Graft vs Host Disease
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on November 09, 2009