Markers of Inflammation in Hematopoietic Stem Cell Transplant

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00579397

Enrollment

Registered

2007-12-24

Start date

2007-04-30

Completion date

2012-12-12

Last updated

2019-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Graft Versus Host Disease

Keywords

Markers of Inflammation, acute graft versus host disease, predicting aGVHD

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 21 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA)	Until September 2008

Secondary

Measure	Time frame
To describe the profile of changes in inflammatory gene products, using RT-MLPA, in pediatric patients receiving stem cell transplant	Until September 2008
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	Until September 2008

Countries

United States

Outcome results