NCT02194439

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
415

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 26, 2021

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

5.7 years

First QC Date

July 11, 2014

Results QC Date

February 6, 2020

Last Update Submit

February 9, 2021

Conditions

Graft-Versus-Host Disease

Keywords

Acute Graft Versus Host DiseaseAffectAnti-inflammatoryAnti-inflammatory AgentsAntigen-Presenting CellsAlloantigenAllogeneicAllograft rejectionAllograft ToleranceAntigensAutoimmunityBiomarkersBiospecimen RepositoryBMTBone Marrow TransplantationCell TransplantationCellsClonal ExpansionComplexCytokineDataDevelopmentEnvironmentFailure (biologic function)GenomicsGraft-vs-Host DiseaseGraft-vs-LeukemiaGVHDGVLHematopoieticHematopoietic Stem Cell TransplantationHCTHSCTIL-33 ReceptorImmune ReconstitutionImmune ResponseInflammatoryModelingNovelNovel therapeuticsOutcomePathway interactionsPeptidesPreventProcessProductionProteomicsRegulatory T-LymphocyteResponseRoleSignalST2TransductionT-cell responseT-cell ActivationT-LymphocytesTissues

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Non Relapse Mortality (NRM) by Age and ST2 at 12 Months Post-HCT

    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.

    1 year

Study Arms (1)

hematopoietic stem cell transplant

procedure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana Unversity Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • 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.

    PMID: 31972009DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood, Plasma, Peripheral Blood Mononuclear Cells (PBMC), Saliva, Bronchoalveolar lavage (BAL)

MeSH Terms

Conditions

Graft vs Host DiseaseAutoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

Title
Sophie Paczesny
Organization
IndianaU
sophpacz@iu.edu
317-278-5487

Study Officials

  • Sophie Paczesny, MD, PhD

    Indiana University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics and Immunology

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 18, 2014

Study Start

January 1, 2014

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

February 26, 2021

Results First Posted

February 26, 2021

Record last verified: 2021-02

Locations

US(1)