Markers of Inflammation in Hematopoietic Stem Cell Transplant

Study Overview
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Brief Summary
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Objectives: To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA) To describe the profile of changes in inflammatory gene products, using RT-MLPA, in pediatric patients receiving stem cell transplant To determine if changes in a specific inflammatory product, or a combination of inflammatory products, can predict grade 2-4 acute graft-versus-host disease

Detailed Description
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Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) is a successful treatment option for multiple malignant diseases (i.e. leukemia) and non-malignant disorders (i.e. metabolic disorders, genetic disorders, immunodeficiencies). Unfortunately, transplantation from an HLA-related family member is only available in 30-40% of stem cell transplant recipients. The other patients requiring HSCT must then receive their stem cells from either a matched-unrelated donor (MUD) or from cord blood. One major limitation upon receiving these unrelated stem cells are acute and chronic graft-versus-host disease. Specifically looking at acute graft-versus-host disease (aGVHD), up to 30% of the recipients of stem cells from an HLA-identical related donor will develop greater or equal to grade 2 of aGVHD despite immunosuppressive prophylaxis. The percentages of patients who develop aGVHD from unrelated donors are even higher. The current standard treatment for aGVHD is corticosteroids. Unfortunately, only 40% of matched-siblings HSCT cases and 25% of MUD SCT cases show a complete response to these steroids. Those patients who do not respond to corticosteroids can show a dismal outcome. Given the poor outcome with refractory GVHD, there has been a lot of interest in trying to predict who will get GVHD. These findings could lead to augmentation of GVHD prophylaxis. The purpose of this study is to look at a series of identified biomarkers to predict aGVHD. Once blood is drawn from the SCT recipient, a multiplex ligation-dependent probe amplification (MLPA) will test different biomarkers in the blood to result in about 30-45 target sequences being examined simultaneously.

Official Title
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Markers of Inflammation in Hematopoietic Stem Cell Transplant

Conditions
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Acute Graft Versus Host Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Objective #1: Healthy adult volunteers, affiliated to Children's Memorial Hospital Male or female Objective #2 & #3: Recipient undergoing an allogeneic stem cell transplant Receiving related or unrelated cord blood, related or unrelated bone marrow or peripheral blood stem cells Any pre-transplant regimen Ages of 0-21 years old Male or female Exclusion Criteria: Inability for subject/parent to understand study and therefore unable to consent Children under 7.0 kgs

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>For Objective #1: Healthy adult volunteers | |
| 2<br>For Objectives #2 & #3: Recipients undergoing an allogeneic stem cell transplant | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA) |  | Until September 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the profile of changes in inflammatory gene products, using RT-MLPA, in pediatric patients receiving stem cell transplant |  | Until September 2008 | 
| To determine if change in a specific inflammatory product, or a combination of inflammatory products, can predict grade 2-4 acute graft-versus-host disease |  | Until September 2008 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Markers of Inflammation, acute graft versus host disease, predicting aGVHD