Markers of Inflammation in Hematopoietic Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT00579397|
Recruitment Status : Completed
First Posted : December 24, 2007
Last Update Posted : May 27, 2009
- 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
|Condition or disease|
|Acute Graft Versus Host Disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Markers of Inflammation in Hematopoietic Stem Cell Transplant|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
For Objective #1:
For Objectives #2 & #3:
- To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA) [ Time Frame: Until September 2008 ]
- To describe the profile of changes in inflammatory gene products, using RT-MLPA, in pediatric patients receiving stem cell transplant [ Time Frame: 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 [ Time Frame: Until September 2008 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579397
|United States, Illinois|
|Children's Memorial Hospital|
|Chicago, Illinois, United States, 60614|
|Principal Investigator:||David A Jacobsohn, MD||Ann & Robert H Lurie Children's Hospital of Chicago|