LeukemiaPhase 3NCT00180089
Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation
A Phase 3 study testing Budesonide in people with Leukemia and Graft-Versus-Host Disease, run by Technische Universität Dresden at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Leukemia, Graft-Versus-Host Disease
- What is being tested?
- Budesonide
- How many people
- 242 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2004to Jan 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Medical Department I, Technical University Hospital
Dresden, 01307
About this study
Official title: Efficacy and Safety of Orale Budesonide in the Prevention of Acute Gastrointestinal Graft-versus-host Disease Following Allogenic Stem Cell Transplantation
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.
Read the 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.
- Conditions
- Leukemia, Graft-Versus-Host Disease
- Being tested
- Budesonide
- Keywords
- graft-versus-host disease, budesonide, stem cell transplantation
- Medical subject headings
- Leukemia, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group
Secondary outcomes (5)
safety
grade of acute GI GVHD
incidence of chronic GI GVHD
incidence of infectious complications
overall and disease-free survival 1 yr after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionMar 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Falk Pharma GmbH
- Investigators
- Stephan Miehlke, Prof., Principal investigator, Medical Department I, Technical University Hospital, Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180089
- Sponsor's protocol ID
- PROGAST
- Status last verified
- Mar 2010
- First submitted
- 9 Sep 2005
- Last updated
- 30 Mar 2010
- Results posted
- No
Publications
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.
PubMed 25425214
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Orale Budesonide in the Prevention of Acute Gastrointestinal Graft-versus-host Disease Following Allogenic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00180089
- Acronym / sponsor ID
- PROGAST
- Conditions
- Leukemia, Graft-Versus-Host Disease
- Keywords
- graft-versus-host disease, budesonide, stem cell transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Dr. Falk Pharma GmbH
- Study start
- Jan 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jan 2010
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- history of allogenic transplantation
- in vitro T-cell depleted transplant
- pretreatment with budesonide within the previous 4 weeks
- known intolerance to budesonide
- gastrointestinal infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide | Drug | – |
Primary outcome
incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group
5 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2010.
- Derived from this study: PubMed 25425214Schmelz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Miehlke, Prof. principal investigator
Medical Department I, Technical University Hospital, Dresden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide in people with Leukemia and Graft-Versus-Host Disease, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00180089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2010.