Allogeneic Hematopoietic Cell Transplant RecipientsNCT00587574
Prospective Phase II Study for Assessment of Regulatory Immune Cell Populations After Allogeneic HSCT
An observational study of Allogeneic Hematopoietic Cell Transplant Recipients, run by Medical University of Vienna at 2 sites in 2 countries.
Trial summary
Allogeneic hematopoietic cell transplantation offers high cure rates for patients with hematological and oncological diseases. Graft-versus-host disease (attack of donor's white blood cells on patient's tissues) is a serious complication also affecting the patient's immune system. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Allogeneic Hematopoietic Cell Transplant Recipients
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2007to Dec 2011
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all consecutive patients after allogeneic hematopoietic cell transplantation
Who may be able to join
- Receiving grafts from either HLA-identical sibling donors or HLA-matched unrelated donors
- Receiving grafts from HLA-mismatched sibling donors or HLA-mismatched unrelated donors
- Receiving either bone marrow, peripheral blood stem cells or cord blood grafts
- Alive on day 100 after transplant
- Age 18 years or above
- Signed written informed consent
Who cannot join
- Lymphocytopenia not allowing immunophenotyping
- Treatment with rituximab after HSCT until study entry
- Hepatitis B and C, HIV infection
- Secondary posttransplant malignancies including EBV-lymphoproliferative disease
- Karnofsky score of 30 or below
- Absence of informed consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Hildegard T Greinix, Professor, +43140400 ext. 4457, hildegard.greinix@meduniwien.ac.at
Hildegard T Greinix, Professor
Czechia1 site
- Active, not recruiting
Institute of Hematology and Blood Transfusions Prague
Prague
About this study
Official title: Prospective Phase II Study for Assessment of Regulatory Immune Cell Populations After Allogeneic Hematopoietic Stem Cell Transplantation and Immunomodulatory Consequences of Chronic Graft-Versus-Host Disease and Therapy
Allogeneic hematopoietic cell transplantation offers high cure rates for patients with hematological and oncological diseases. Graft-versus-host disease (attack of donor's white blood cells on patient's tissues) is a serious complication also affecting the patient's immune system. Therefore, patients in the early phase after allogeneic cell transplantation are at high risk for severe infectious complications. So far, no predictive biomarkers for the development of the chronic form of graft-versus-host disease are available. By analysing serially immune cell populations of the peripheral blood we will investigate whether certain subsets of cells are associated with development of chronic graft-versus-host disease. In addition, the patients' immune regeneration will be evaluated by serial analyses of peripheral blood immune cell populations 3 months to 2 years after allogeneic cell transplantation.
- Keywords
- chronic graft-versus-host disease
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| I | Chronic graft-versus-host disease | |
| II | No chronic graft-versus-host disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of perturbed B cell homeostasis with chronic graft-versus-host disease activity of immune system
Measured: October 2007 until December 2010
Secondary outcomes (5)
Difference of time-dependent pattern of immune reconstitution after allogeneic cell transplantation between patients with and without chronic graft-versus-host disease
Measured: October 2010 until December 2010
Compare number of clinically defined bacterial, viral and fungal infectious episodes between patients with and without chronic graft-versus-host disease
Measured: October 2007 until December 2010
Compare the number of circulating T, DC, NK subsets in patients with and without chronic GVHD to identify their respective role in development and prolongation of chronic GVHD
Measured: October 2007 until December 2010
Investigate the impact of different immunosuppressive/immunomodulatory treatments for chronic GVHD on various immune cell populations
Measured: October 2007 until December 2010
Assess the chimerism of antigen-presenting cells in circulation and tissue specimens and correlate it with occurrence of chronic GVHD
Measured: October 2007 until December 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2010 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Cell Transplant RecipientsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Hildegard T Greinix, Professor, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587574
- Sponsor's protocol ID
- 488/2007
- Other IDs
- EK Nr 488/2007
- Status last verified
- Oct 2007
- First submitted
- 21 Dec 2007
- Last updated
- 7 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase II Study for Assessment of Regulatory Immune Cell Populations After Allogeneic Hematopoietic Stem Cell Transplantation and Immunomodulatory Consequences of Chronic Graft-Versus-Host Disease and Therapy
- ClinicalTrials.gov ID
- NCT00587574
- Acronym / sponsor ID
- 488/2007
- Keywords
- chronic graft-versus-host disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 7 Jan 2008 (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.
Allogeneic hematopoietic cell transplantation offers high cure rates for patients with hematological and oncological diseases. Graft-versus-host disease (attack of donor's white blood cells on patient's tissues) is a serious complication also affecting the patient's immune system. Therefore, patients in the early phase after allogeneic cell transplantation are at high risk for severe infectious complications. So far, no predictive biomarkers for the development of the chronic form of graft-versus-host disease are available. By analysing serially immune cell populations of the peripheral blood we will investigate whether certain subsets of cells are associated with development of chronic graft-versus-host disease. In addition, the patients' immune regeneration will be evaluated by serial analyses of peripheral blood immune cell populations 3 months to 2 years after allogeneic cell transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | – | –Chronic graft-versus-host disease |
| II | – | –No chronic graft-versus-host disease |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all consecutive patients after allogeneic hematopoietic cell transplantation
Key inclusion criteria (6 listed)
- Receiving grafts from either HLA-identical sibling donors or HLA-matched unrelated donors
- Receiving grafts from HLA-mismatched sibling donors or HLA-mismatched unrelated donors
- Receiving either bone marrow, peripheral blood stem cells or cord blood grafts
- Alive on day 100 after transplant
- Age 18 years or above
Key exclusion criteria (6 listed)
- Lymphocytopenia not allowing immunophenotyping
- Treatment with rituximab after HSCT until study entry
- Hepatitis B and C, HIV infection
- Secondary posttransplant malignancies including EBV-lymphoproliferative disease
- Karnofsky score of 30 or below
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of perturbed B cell homeostasis with chronic graft-versus-host disease activity of immune system
Time frame: October 2007 until December 2010
5 secondary outcomes
Difference of time-dependent pattern of immune reconstitution after allogeneic cell transplantation between patients with and without chronic graft-versus-host disease
Time frame: October 2010 until December 2010
Compare number of clinically defined bacterial, viral and fungal infectious episodes between patients with and without chronic graft-versus-host disease
Time frame: October 2007 until December 2010
Compare the number of circulating T, DC, NK subsets in patients with and without chronic GVHD to identify their respective role in development and prolongation of chronic GVHD
Time frame: October 2007 until December 2010
Investigate the impact of different immunosuppressive/immunomodulatory treatments for chronic GVHD on various immune cell populations
Time frame: October 2007 until December 2010
Assess the chimerism of antigen-presenting cells in circulation and tissue specimens and correlate it with occurrence of chronic GVHD
Time frame: October 2007 until December 2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2008.
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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 principal investigator
Medical University of Vienna
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allogeneic Hematopoietic Cell Transplant Recipients, run by Medical University of Vienna at 2 sites in 2 countries.
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 6 inclusion and 6 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 7 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Czechia. 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.
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, Professor (+43140400 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?
Correlation of perturbed B cell homeostasis with chronic graft-versus-host disease activity of immune system (time frame: October 2007 until December 2010). 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 7 Jan 2008.