Clinical trial NCT00587574: Prospective Phase II Study for Assessment of Regulatory Immune Cell Populations After Allogeneic HSCT
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allogeneic Hematopoietic Cell Transplant Recipients
Keywords: chronic graft-versus-host disease
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-01-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all consecutive patients after allogeneic hematopoietic cell transplantation

Brief 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. 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.


Eligibility 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

Primary outcomes:
measure: Correlation of perturbed B cell homeostasis with chronic graft-versus-host disease activity of immune system
timeFrame: October 2007 until December 2010
Secondary outcomes:
measure: Difference of time-dependent pattern of immune reconstitution after allogeneic cell transplantation between patients with and without chronic graft-versus-host disease
timeFrame: October 2010 until December 2010
measure: Compare number of clinically defined bacterial, viral and fungal infectious episodes between patients with and without chronic graft-versus-host disease
timeFrame: October 2007 until December 2010
measure: 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
timeFrame: October 2007 until December 2010
measure: Investigate the impact of different immunosuppressive/immunomodulatory treatments for chronic GVHD on various immune cell populations
timeFrame: October 2007 until December 2010
measure: Assess the chimerism of antigen-presenting cells in circulation and tissue specimens and correlate it with occurrence of chronic GVHD
timeFrame: October 2007 until December 2010
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Prague
country: Czech Republic
facility: Institute of Hematology and Blood Transfusions Prague
Study officials:
affiliation: Medical University of Vienna
name: Hildegard T Greinix, Professor
role: PRINCIPAL_INVESTIGATOR
References: