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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Leukemia Graft-Versus-Host Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Budesonide

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No