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

Technische Universität Dresden242 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

242

Conditions

Leukemia Graft-Versus-Host Disease

Interventions

BudesonideDRUG

Eligibility

Sex: ALLMin age: 12 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical Department I, Technical University Hospital

Dresden, Germany

Outcomes

Primary Outcomes

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

Secondary Outcomes

safety

grade of acute GI GVHD

incidence of chronic GI GVHD

incidence of infectious complications

overall and disease-free survival 1 yr after transplant

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.