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

Condition(s) targeted: Leukemia; Graft-Versus-Host Disease

Intervention: Budesonide (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Dresden University of Technology

Official(s) and/or principal investigator(s):
Stephan Miehlke, Prof., Principal Investigator, Affiliation: Medical Department I, Technical University Hospital, Dresden, Germany

Overall contact:
Stephan Miehlke, Prof., Phone: +49 351 458, Ext: 5645, Email: stephan.miehlke@uniklinikum-dresden.de

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.

Official title: Efficacy and Safety of Orale Budesonide in the Prevention of Acute Gastrointestinal Graft-Versus-Host Disease Following Allogenic Stem Cell Transplantation

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Secondary outcome:

safety

grade of acute GI GVHD

incidence of chronic GI GVHD

incidence of infectious complications

overall and disease-free survival 1 yr after transplant

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.

Minimum age: 12 Years. Maximum age: 65 Years. Gender(s): Both.

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

Stephan Miehlke, Prof., Phone: +49 351 458, Ext: 5645, Email: stephan.miehlke@uniklinikum-dresden.de

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

Starting date: January 2004
Ending date: August 2005
Last updated: February 12, 2007