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Markers of Inflammation in Hematopoietic Stem Cell Transplant

This study has been completed.
Sponsor:
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT00579397
First received: December 21, 2007
Last updated: May 26, 2009
Last verified: May 2009
History of Changes
  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

Condition
Acute Graft Versus Host Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Markers of Inflammation in Hematopoietic Stem Cell Transplant

Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA) [ Time Frame: Until September 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

2.5 mL's of whole blood are obtained one time a week for the first 100 days of transplant


Estimated Enrollment: 30
Study Start Date: April 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1

For Objective #1:

  • Healthy adult volunteers
2

For Objectives #2 & #3:

  • Recipients undergoing an allogeneic stem cell transplant

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing a hematopoietic stem cell transplant at Children's Memorial Hospital

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00579397

Locations
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: David A Jacobsohn, MD Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

No publications provided

Responsible Party: David Jacobsohn, MD, Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT00579397     History of Changes
Other Study ID Numbers: SCT 0407
Study First Received: December 21, 2007
Last Updated: May 26, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Markers of Inflammation
acute graft versus host disease
predicting aGVHD

Additional relevant MeSH terms:
Graft vs Host Disease
Inflammation
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013