Clinical trial · Interventional
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
NCT00180089CI-TRIAL-00003306completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graft-Versus-Host Disease | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Budesonide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group
Secondary outcomes (5)
- measure
- safety
- measure
- grade of acute GI GVHD
- measure
- incidence of chronic GI GVHD
- measure
- incidence of infectious complications
- measure
- overall and disease-free survival 1 yr after transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSchmelz 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. PMID 25425214