Chronic Graft-Versus Host DiseasePhase 2NCT00271869
Treatment of Chronic GVHD of Liver or Lungs by ECP
A Phase 2 study testing Extracorporeal photoimmunotherapy in people with Chronic Graft-Versus Host Disease, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Chronic graft-versus-host disease (GVHD) is a major complication of allogeneic hematopoietic stem cell transplantation and the leading cause of death more than 2 years after transplantation.During the past 30 years survival of patients with chronic GVHD has not improved and steroids remained the most often used… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Graft-Versus Host Disease
- What is being tested?
- Extracorporeal photoimmunotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2005to not given
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of at least one diagnostic clinical sign of chronic GVHD or an appropriate constellation of distinctive signs confirmed by biopsy or other relevant diagnostic tests
- Presence of liver or lung manifestations of chronic GVHD
- Indication for systemic immunosuppressive therapy defined according to NIH consensus
- No prior immunosuppressive therapy for chronic GVHD of the liver or lungs
- Adequate renal, hepatic, pulmonary and cardiac function
- Karnofsky performance score >- 50%
- Women of childbearing potential must agree to use a reliable method of birth control for the duration of the study
- Signed written informed consent
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Department of Medicine I, BMT
Vienna, A-1090
Hildegard T Greinix, Professor of Medicine, 43-1-40400 ext. 4457, hildegard.greinix@meduniwien.ac.at
Hildegard T Greinix, Professor of Medicine
About this study
Official title: Phase II Study for Treatment of Chronic Graft-Versus-Host Disease of the Liver or Lungs With Adjunct Extracorporeal Photoimmunotherapy
Chronic graft-versus-host disease (GVHD) is a major complication of allogeneic hematopoietic stem cell transplantation and the leading cause of death more than 2 years after transplantation.During the past 30 years survival of patients with chronic GVHD has not improved and steroids remained the most often used therapy. Extracorporeal photoimmunotherapy (ECP)has shown to be efficacious in patients with GVHD. We propose a phase II study to evaluate the safety and efficacy of ECP as adjunct first-line therapy in patients with newly diagnosed chronic GVHD of liver or lungs and need for systemic immunosuppression defined according to the NIH consensus criteria.
- Conditions
- Chronic Graft-Versus Host Disease
- Being tested
- Extracorporeal photoimmunotherapy
- Keywords
- hematopoietic stem cell transplantation, graft-versus-host disease, treatment
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal photoimmunotherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
GVHD response of the liver or lungs
Secondary outcomes (9)
transplant-related mortality
relapse-free survival
overall survival
time to complete resolution of chronic GVHD to first-line immunosuppressive therapy
time to discontinuation of immunosuppressive therapy
duration of response to first-line immunosuppressive therapy
percentage of patients in need of secondary treatment for chronic GVHD
incidence of bacterial, viral and fungal infections
side effects of ECP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Graft-Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Hildegard T Greinix, Professor of Medicine, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271869
- Sponsor's protocol ID
- EK Nr. 368/2005
- Status last verified
- Dec 2005
- First submitted
- 3 Jan 2006
- Last updated
- 4 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study for Treatment of Chronic Graft-Versus-Host Disease of the Liver or Lungs With Adjunct Extracorporeal Photoimmunotherapy
- ClinicalTrials.gov ID
- NCT00271869
- Acronym / sponsor ID
- EK Nr. 368/2005
- Conditions
- Chronic Graft-Versus Host Disease
- Keywords
- hematopoietic stem cell transplantation, graft-versus-host disease, treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2005
- First posted
- 4 Jan 2006 (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.
Chronic graft-versus-host disease (GVHD) is a major complication of allogeneic hematopoietic stem cell transplantation and the leading cause of death more than 2 years after transplantation.During the past 30 years survival of patients with chronic GVHD has not improved and steroids remained the most often used therapy. Extracorporeal photoimmunotherapy (ECP)has shown to be efficacious in patients with GVHD. We propose a phase II study to evaluate the safety and efficacy of ECP as adjunct first-line therapy in patients with newly diagnosed chronic GVHD of liver or lungs and need for systemic immunosuppression defined according to the NIH consensus criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Presence of at least one diagnostic clinical sign of chronic GVHD or an appropriate constellation of distinctive signs confirmed by biopsy or other relevant diagnostic tests
- Presence of liver or lung manifestations of chronic GVHD
- Indication for systemic immunosuppressive therapy defined according to NIH consensus
- No prior immunosuppressive therapy for chronic GVHD of the liver or lungs
- Adequate renal, hepatic, pulmonary and cardiac function
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Extracorporeal photoimmunotherapy | Procedure or surgery | – |
Primary outcome
GVHD response of the liver or lungs
9 secondary outcomes
transplant-related mortality
relapse-free survival
overall survival
time to complete resolution of chronic GVHD to first-line immunosuppressive therapy
time to discontinuation of immunosuppressive therapy
duration of response to first-line immunosuppressive therapy
percentage of patients in need of secondary treatment for chronic GVHD
incidence of bacterial, viral and fungal infections
side effects of ECP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2006.
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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.
Hildegard T Greinix, Professor of Medicine principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Extracorporeal photoimmunotherapy in people with Chronic Graft-Versus Host Disease, run by Medical University of Vienna at 1 site in Austria.
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 8 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Jan 2006. 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 Austria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hildegard T Greinix, MD (43-1-40400 ext. 4457, hildegard.greinix@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GVHD response of the liver or lungs. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jan 2006.