Expired Study
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Chicago, Illinois 60614


Purpose:

Objectives: 1. To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA) 2. To describe the profile of changes in inflammatory gene products, using RT-MLPA, in pediatric patients receiving stem cell transplant 3. 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


Study summary:

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.


Criteria:

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


NCT ID:

NCT00579397


Primary Contact:

Principal Investigator
David A Jacobsohn, MD
Children's Memorial Hospital


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60614
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 16, 2018

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