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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Allogeneic Hematopoietic Cell Transplant Recipients

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| I<br>Chronic graft-versus-host disease | |
| II<br>No chronic graft-versus-host disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of perturbed B cell homeostasis with chronic graft-versus-host disease activity of immune system |  | October 2007 until December 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of time-dependent pattern of immune reconstitution after allogeneic cell transplantation between patients with and without chronic graft-versus-host disease |  | 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 |  | 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 |  | October 2007 until December 2010 | 
| Investigate the impact of different immunosuppressive/immunomodulatory treatments for chronic GVHD on various immune cell populations |  | 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 |  | October 2007 until December 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic graft-versus-host disease