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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014