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OpenTrials
Completed

NCT Number: NCT00579397

Markers of Inflammation in Hematopoietic Stem Cell Transplant

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

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Key information

Conditions

Acute Graft Versus Host Disease

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA)

    Time frame: Until September 2008

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2012
First posted
Dec 24, 2007
Registry last updated
Aug 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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