Prospective Phase II Study for Assessment of Regulatory Immune Cell Populations After Allogeneic HSCT

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00587574
First received: December 21, 2007
Last updated: January 4, 2008
Last verified: October 2007
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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

Resource links provided by NLM:


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

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

No publications provided

Responsible Party: Christoph Zielinski, Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00587574     History of Changes
Other Study ID Numbers: 488/2007, EK Nr 488/2007
Study First Received: December 21, 2007
Last Updated: January 4, 2008
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
chronic graft-versus-host disease

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014