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Sponsored by: |
Medical University of Vienna |
Information provided by: | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00587574 |
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.
Condition |
Allogeneic Hematopoietic Cell Transplant Recipients |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
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 |
peripheral blood mononuclear cells as cell pellets and DNA, plasma and serum samples, tissue biopsy samples, urine
Estimated Enrollment: | 150 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
I
Chronic graft-versus-host disease
|
II
No chronic graft-versus-host disease
|
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
all consecutive patients after allogeneic hematopoietic cell transplantation
Inclusion Criteria:
Exclusion Criteria:
Contact: Hildegard T Greinix, Professor | +43140400 ext 4457 | hildegard.greinix@meduniwien.ac.at |
Contact: Winfried Pickl, Professor | +434277 ext 64945 | winfried.pickl@meduniwien.ac.at |
Austria | |||||
Medical University of Vienna | Recruiting | ||||
Vienna, Austria, 1090 | |||||
Contact: Hildegard T Greinix, Professor +43140400 ext 4457 hildegard.greinix@meduniwien.ac.at | |||||
Principal Investigator: Hildegard T Greinix, Professor | |||||
Czech Republic | |||||
Institute of Hematology and Blood Transfusions Prague | Active, not recruiting | ||||
Prague, Czech Republic |
Medical University of Vienna |
Principal Investigator: | Hildegard T Greinix, Professor | Medical University of Vienna |
Responsible Party: | Medical University of Vienna ( Christoph Zielinski, Professor ) |
Study ID Numbers: | 488/2007, EK Nr 488/2007 |
First Received: | December 21, 2007 |
Last Updated: | January 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00587574 |
Health Authority: | Austria: Ethikkommission |
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