Clinical trial · Observational

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

NCT02194439CI-TRIAL-00050346completedResults postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Graft-Versus-Host Disease	—	UNRESOLVED	—

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (1)

label
hematopoietic stem cell transplant
description
procedure

Primary outcomes (1)

measure
Number of Participants With Non Relapse Mortality (NRM) by Age and ST2 at 12 Months Post-HCT
timeFrame
1 year
description
To measure stimulation-2 (ST2) pre-HCT by number of participants at 12 months post-HCT for non-relapse mortality according to ST2 values and age less than or equal to 10 and greater than 10 using landmark analyses.

Eligibility

Eligibility (as posted)

Sex: All

Show eligibility criteria text

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.

References

Publications (1)

DERIVEDRowan 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. PMID 31972009

Registry

Dates and enrollment

Start: Jan 1, 2014
Primary completion: Sep 30, 2019
Completion: Sep 30, 2019
First posted: Jul 18, 2014
Last update posted: Feb 26, 2021
Results first posted: Feb 26, 2021
Enrollment: 415 (actual)
Lead sponsor: Indiana University OTHER
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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