Markers of Inflammation in Hematopoietic Stem Cell Transplant

Acute Graft Versus Host Disease Clinical Trial

Official title:

Markers of Inflammation in Hematopoietic Stem Cell Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00579397
• Other study ID #: SCT 0407
• Status: Completed
• Start date: April 2007
• Est. completion date: December 12, 2012

Study information

• Verified date: August 2019
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 12, 2012
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Graft Versus Host Disease
• Graft vs Host Disease
• Inflammation

Locations

Country	Name	City	State
United States	Lurie Children's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA)		Until September 2008
Secondary	To describe the profile of changes in inflammatory gene products, using RT-MLPA, in pediatric patients receiving stem cell transplant		Until September 2008
Secondary	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