Acute Graft Versus Host DiseaseNCT00579397
Markers of Inflammation in Hematopoietic Stem Cell Transplant
An observational study of Acute Graft Versus Host Disease, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Graft Versus Host Disease
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to 12 Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients undergoing a hematopoietic stem cell transplant at Children's Memorial Hospital
Who may be able to join
- 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
Show all 9Show fewer
- Any pre-transplant regimen
- Ages of 0-21 years old
- Male or female
Who cannot join
- Inability for subject/parent to understand study and therefore unable to consent
- Children under 7.0 kgs
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Acute Graft Versus Host Disease
- Keywords
- Markers of Inflammation, acute graft versus host disease, predicting aGVHD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | For Objective #1: * Healthy adult volunteers | |
| 2 | For Objectives #2 \& #3: * Recipients undergoing an allogeneic stem cell transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA)
Measured: Until September 2008
Secondary outcomes (2)
To describe the profile of changes in inflammatory gene products, using RT-MLPA, in pediatric patients receiving stem cell transplant
Measured: 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
Measured: Until September 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startApr 2007
- Primary completionOct 2008
- Study completion12 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft Versus Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reggie E Duerst, MD, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Reggie Duerst, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579397
- Sponsor's protocol ID
- SCT 0407
- Status last verified
- Aug 2019
- First submitted
- 21 Dec 2007
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Inflammation in Hematopoietic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT00579397
- Acronym / sponsor ID
- SCT 0407
- Conditions
- Acute Graft Versus Host Disease
- Keywords
- Markers of Inflammation, acute graft versus host disease, predicting aGVHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- 12 Dec 2012 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –For Objective #1: * Healthy adult volunteers |
| 2 | – | –For Objectives #2 \& #3: * Recipients undergoing an allogeneic stem cell transplant |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients undergoing a hematopoietic stem cell transplant at Children's Memorial Hospital
Key inclusion criteria (9 listed)
- Objective #1:
- Healthy adult volunteers, affiliated to Children's Memorial Hospital
- Male or female
- Objective #2 \& #3:
- Recipient undergoing an allogeneic stem cell transplant
Key exclusion criteria (2 listed)
- Inability for subject/parent to understand study and therefore unable to consent
- Children under 7.0 kgs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA)
Time frame: Until September 2008
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reggie Duerst, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Graft Versus Host Disease, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To show feasibility and reproducibility of performing a multiplex ligation-dependent amplification procedure (RT-MLPA) (time frame: Until September 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.