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

Indiana University

Status: Completed

Conditions: Graft-Versus-Host Disease

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02194439

1405976232

1R01HD074587-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 415 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

415 participants in 1 patient group

hematopoietic stem cell transplant

Description:

procedure