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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180089
• Other study ID #: PROGAST
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: March 29, 2010
• Start date: January 2004
• Est. completion date: January 2010

Study information

• Verified date: March 2010
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: January 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-Versus-Host Disease
• Leukemia

Intervention

Drug:
• Budesonide

Locations

Country	Name	City	State
Germany	Medical Department I, Technical University Hospital	Dresden

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group
Secondary	safety
Secondary	grade of acute GI GVHD
Secondary	incidence of chronic GI GVHD
Secondary	incidence of infectious complications
Secondary	overall and disease-free survival 1 yr after transplant