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

Technische Universität Dresden

Status and phase: Completed; Phase 3

Conditions: Graft-Versus-Host Disease; Leukemia

Treatments: Drug: Budesonide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00180089

PROGAST

Details and patient eligibility

About

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.

Full 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.

Enrollment: 242 estimated patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind