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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00180089

Enrollment

242

Registered

2005-09-16

Start date

2004-01-31

Completion date

2010-01-31

Last updated

2010-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft-Versus-Host Disease, Leukemia

Keywords

graft-versus-host disease, budesonide, stem cell transplantation

Brief 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.

Detailed description

Interventions

DRUGBudesonide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

12 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group	—

Secondary

Measure	Time frame
safety	—
grade of acute GI GVHD	—
incidence of chronic GI GVHD	—
incidence of infectious complications	—
overall and disease-free survival 1 yr after transplant	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026