Prospective Phase II Study for Assessment of Regulatory Immune Cell Populations After Allogeneic HSCT - Full Text View

Purpose

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

U.S. FDA Resources

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

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Correlation of perturbed B cell homeostasis with chronic graft-versus-host disease activity of immune system [ Time Frame: October 2007 until December 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Investigate the impact of different immunosuppressive/immunomodulatory treatments for chronic GVHD on various immune cell populations [ Time Frame: October 2007 until December 2010 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

all consecutive patients after allogeneic hematopoietic cell transplantation

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587574

Contacts


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

Locations


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

Sponsors and Collaborators

Medical University of Vienna

Investigators


Principal Investigator:	Hildegard T Greinix, Professor	Medical University of Vienna

More Information

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

Keywords provided by Medical University of Vienna:

chronic graft-versus-host disease

Study placed in the following topic categories:

Graft versus host disease

Graft vs Host Disease

Homologous wasting disease

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00587574