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Bridging Pediatric and Adult Biomarkers in Graft-Versus-Host Disease

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ClinicalTrials.gov Identifier: NCT02194439
Recruitment Status : Active, not recruiting
First Posted : July 18, 2014
Last Update Posted : June 26, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Sophie Paczesny, Indiana University

Brief Summary:
This study is designed to collect longitudinal biological samples from patients after hematopoietic cell transplantation (HCT) cared for at multiple bone marrow transplant centers to validate biomarkers of both acute and chronic GVHD as well as for use in future unspecified research. The centers include Dana-Farber Cancer Institute and Boston's Children's Hospital, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Fred Hutchinson Cancer Research Center, Texas Children's Hospital, Children's National Medical Center, and Indiana University Simon Cancer Center.

Condition or disease
Graft-Versus-Host Disease

Detailed Description:

After informed consent is signed, this study will involve 1) collection of basic HCT data and clinical data available in the medical record and 2) providing blood (and saliva in occasional cases) samples for processing, storage, DNA extraction, and analysis (including a seven biomarker protein panel as well as future unspecified research purposes).

Pediatric and adult patients will be included (all adult patients will be from the Fred Hutchinson Cancer Research Center, the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, and the Indiana University Simon Cancer Center).

Primary Objective:

1. To confirm that ST2 alone or the seven-biomarker panel measured at initiation of GVHD therapy predict a) D180 post-therapy non-relapse mortality; b) D28 post-therapy non-response, and c) GVHD grade 1-4 onset D180 post-therapy non-relapse mortality.

Secondary Objective:

  1. To demonstrate that ST2 alone or the seven-biomarker panel measured at day 14 or day 21 post-HCT (or a combination of these time points) predicts D180 post-HCT non-relapse mortality.
  2. To demonstrate that ST2 alone or the seven-biomarker panel measured at initiation of GVHD symptoms/therapy diagnose acute GVHD as compared to other complications presenting with similar symptoms (drug rash, CMV, Clostridium enteritis).
  3. To demonstrate that ST2 alone or the seven-biomarker panel measured at initiation of GVHD symptoms/therapy diagnose the severity of acute GVHD at onset and maximum.
  4. To develop a repository of biospecimens linked to clinical data for future unspecified research.

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Study Type : Observational
Estimated Enrollment : 430 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bridging Pediatric and Adult Biomarkers in Graft-Versus-Host Disease
Study Start Date : January 2014
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2022


Group/Cohort
hematopoietic stem cell transplant
procedure



Primary Outcome Measures :
  1. Confirm Biomarkers Predictive Efficacy [ Time Frame: 2 years ]

    To confirm the efficacy of ST2 alone or the seven-biomarker panel when measured at the initiation of GVHD therapy to predict:

    • 6 month post-therapy non-relapse mortality
    • D28 post-therapy non-response
    • GVHD grade 1-4 onset 6 month post-therapy non-relapse mortality


Secondary Outcome Measures :
  1. Demonstrate Efficacy of Biomarkers to Predict Non-Relapse Mortality [ Time Frame: 2 years ]
    To demonstrate the efficacy of ST2 alone or the seven-biomarker panel measured at day 14 or day 21 post-HCT (or a combination of these time points) to predict 6 month post-HCT non-relapse mortality.


Other Outcome Measures:
  1. Demonstrate Efficacy of Biomarkers to Diagnose GVHD [ Time Frame: 2 years ]
    To demonstrate the efficacy of ST2 alone or the seven-biomarker panel measured at initiation of GVHD symptoms/therapy to diagnose GVHD as compared to other complications presenting with similar symptoms (drug rash, CMV, Clostridium enteritis).

  2. Demonstrate Efficacy of Biomarkers to Diagnose Severity of GVHD [ Time Frame: 2 years ]
    To demonstrate the efficacy of ST2 alone or the seven-biomarker panel measured at initiation of GVHD symptoms/therapy to diagnose the severity of acute GVHD at onset and maximum.


Biospecimen Retention:   Samples With DNA
Whole Blood, Plasma, Peripheral Blood Mononuclear Cells (PBMC), Saliva, Bronchoalveolar lavage (BAL)


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients receiving an allogeneic hematopoietic stem cell transplant, cord blood transplant, bone marrow transplant, T cell depleted marrow, donor lymphocyte infusion (DLI), or donor cellular infusion (DCI) from Dana-Farber Cancer Institute and Boston Children's Hospital, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Fred Hutchinson Cancer Research Center, Texas Children's Hospital, Children's National Medical Center, and Indiana University Simon Cancer Center
Criteria

Inclusion Criteria: - All patients receiving an allogeneic hematopoietic stem cell transplant, cord blood transplant, bone marrow transplant, T cell depleted marrow, donor lymphocyte infusion (DLI), or donor cellular infusion (DCI) can be included.

Exclusion Criteria: - patients not receiving an allogeneic hematopoietic stem cell transplant, cord blood transplant, bone marrow transplant, T cell depleted marrow, donor lymphocyte infusion (DLI), or donor cellular infusion (DCI) will be excluded.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194439


Locations
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United States, Indiana
Indiana Unversity Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Study Chair: Sophie Paczesny, MD, PhD Indiana University

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Responsible Party: Sophie Paczesny, Professor of Pediatrics and Immunology, Indiana University
ClinicalTrials.gov Identifier: NCT02194439     History of Changes
Other Study ID Numbers: 1405976232
1R01HD074587-01 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019

Keywords provided by Sophie Paczesny, Indiana University:
Acute Graft Versus Host Disease
Affect
Anti-inflammatory
Anti-inflammatory Agents
Antigen-Presenting Cells
Alloantigen
Allogeneic
Allograft rejection
Allograft Tolerance
Antigens
Autoimmunity
Biomarkers
Biospecimen Repository
BMT
Bone Marrow Transplantation
Cell Transplantation
Cells
Clonal Expansion
Complex
Cytokine
Data
Development
Environment
Failure (biologic function)
Genomics
Graft-vs-Host Disease
Graft-vs-Leukemia
GVHD
GVL
Hematopoietic

Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Anti-Inflammatory Agents