Clinical trial NCT02194439: Bridging Pediatric and Adult Biomarkers in Graft-Versus-Host Disease
Official title: Bridging Pediatric and Adult Biomarkers in Graft-Versus-Host Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graft-Versus-Host Disease
Keywords: 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
Hematopoietic Stem Cell Transplantation
HCT
HSCT
IL-33 Receptor
Immune Reconstitution
Immune Response
Inflammatory
Modeling
Novel
Novel therapeutics
Outcome
Pathway interactions
Peptides
Prevent
Process
Production
Proteomics
Regulatory T-Lymphocyte
Response
Role
Signal
ST2
Transduction
T-cell response
T-cell Activation
T-Lymphocytes
Tissues
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-07-18
Enrollment: 415
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Non Relapse Mortality (NRM) by Age and ST2 at 12 Months Post-HCT
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana Unversity Melvin and Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Sophie Paczesny, MD, PhD
role: STUDY_CHAIR
References:
citation: Rowan CM, Pike F, Cooke KR, Krance R, Carpenter PA, Duncan C, Jacobsohn DA, Bollard CM, Cruz CRY, Malatpure A, Farag SS, Renbarger J, Liu H, Bakoyannis G, Hanash S, Paczesny S. Assessment of ST2 for risk of death following graft-versus-host disease in pediatric and adult age groups. Blood. 2020 Apr 23;135(17):1428-1437. doi: 10.1182/blood.2019002334.