Back to resultsBudesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation
Primary Purpose
Leukemia, Graft-Versus-Host Disease
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Budesonide
Sponsored by
About this trial
This is an interventional prevention trial for Leukemia focused on measuring graft-versus-host disease, budesonide, stem cell transplantation
Eligibility Criteria
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
Sites / Locations
- Medical Department I, Technical University Hospital
Outcomes
Primary Outcome Measures
incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group
Secondary Outcome Measures
safety
grade of acute GI GVHD
incidence of chronic GI GVHD
incidence of infectious complications
overall and disease-free survival 1 yr after transplant
Full Information
NCT ID
NCT00180089
First Posted
September 9, 2005
Last Updated
March 29, 2010
Sponsor
Technische Universität Dresden
Collaborators
Dr. Falk Pharma GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00180089
Brief Title
Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation
Official Title
Efficacy and Safety of Orale Budesonide in the Prevention of Acute Gastrointestinal Graft-versus-host Disease Following Allogenic Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
January 2010 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Technische Universität Dresden
Collaborators
Dr. Falk Pharma GmbH
4. Oversight
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Graft-Versus-Host Disease
Keywords
graft-versus-host disease, budesonide, stem cell transplantation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
242 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Budesonide
Primary Outcome Measure Information:
Title
incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group
Secondary Outcome Measure Information:
Title
safety
Title
grade of acute GI GVHD
Title
incidence of chronic GI GVHD
Title
incidence of infectious complications
Title
overall and disease-free survival 1 yr after transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Miehlke, Prof.
Organizational Affiliation
Medical Department I, Technical University Hospital, Dresden, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Department I, Technical University Hospital
City
Dresden
ZIP/Postal Code
01307
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
25425214
Citation
Schmelz R, Bornhauser M, Schetelig J, Kiani A, Platzbecker U, Schwanebeck U, Grahlert X, Uharek L, Aust D, Baretton G, Schwerdtfeger R, Hampe J, Greinwald R, Mueller R, Ehninger G, Miehlke S. Randomised, double-blind, placebo-controlled trial of oral budesonide for prophylaxis of acute intestinal graft-versus-host disease after allogeneic stem cell transplantation (PROGAST). BMC Gastroenterol. 2014 Nov 26;14:197. doi: 10.1186/s12876-014-0197-7.
Results Reference
derived
Learn more about this trial
Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation
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