Markers of Inflammation in Hematopoietic Stem Cell Transplant - Full Text View

Sponsored by:	Children's Memorial Hospital
Information provided by:	Children's Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00579397

Purpose

Objectives:

To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA)
To describe the profile of changes in inflammatory gene products, using RT-MLPA, in pediatric patients receiving stem cell transplant
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

U.S. FDA Resources

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

Further study details as provided by Children's Memorial Hospital:

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

Biospecimen Description:

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
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 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 kg's

Contacts and Locations

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

Contacts

Contact: David A Jacobsohn, MD	773-880-3694	djacobsohn@childrensmemorial.org
Contact: Colleen E Schaefer, BS	773-880-3459	cschaefer@childrensmemorial.org

Locations

United States, Illinois
Children's Memorial Hospital	Recruiting
Chicago, Illinois, United States, 60614
Principal Investigator: David A Jacobsohn, MD

Sponsors and Collaborators

Children's Memorial Hospital

Investigators

Principal Investigator:

David A Jacobsohn, MD

Children's Memorial Hospital

More Information

Responsible Party:	Children's Memorial Hospital ( David Jacobsohn, MD )
Study ID Numbers:	SCT 0407
Study First Received:	December 21, 2007
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00579397
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Memorial Hospital:

Markers of Inflammation
acute graft versus host disease
predicting aGVHD

Study placed in the following topic categories:

Graft versus host disease
Graft vs Host Disease
Homologous wasting disease
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009