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

December 21, 2007
May 26, 2009
April 2007
October 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00579397 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Markers of Inflammation in Hematopoietic Stem Cell Transplant
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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

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

Acute Graft Versus Host Disease
Not Provided
  • 1

    For Objective #1:

    • Healthy adult volunteers
  • 2

    For Objectives #2 & #3:

    • Recipients undergoing an allogeneic stem cell transplant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
up to 21 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00579397
SCT 0407
No
David Jacobsohn, MD, Children's Memorial Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
Not Provided
Principal Investigator: David A Jacobsohn, MD Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP