Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation - Full Text View

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:	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:

MedlinePlus related topics: Leukemia

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:	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

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

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

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 Dresden University of Technology:

graft-versus-host disease
budesonide
stem cell transplantation

Additional relevant MeSH terms:

Graft vs Host Disease
Leukemia
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 12, 2012