Identification of Novel Targetable Kinases in SR-a GvHD

Investigation of Novel Targetable Kinases in Steroid-refractory Acute Graft-versus-host Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04342442

Enrollment

Registered

2020-04-13

Start date

2017-01-01

Completion date

2019-12-31

Last updated

2020-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Versus Host Disease

Keywords

Steroid-refractory GvHD, Myeloid cells, Allogeneic hematopoietic cell transplantation (allo-HCT)

Brief summary

In this study, the investigators aim to identify novel targetable kinases in SR-a GvHD patient samples and investigate their role in different immune cell subtypes.

Detailed description

Corticosteroids are the first-line treatment of a GvHD, however many patients do not respond to corticosteroids. Patients with steroid-refractory a GvHD (SR-a GVHD) have a low 1-year survival rate. In this study, the investigators aim to identify and validate novel targetable kinases in SR-a GvHD patient peripheral blood mononuclear cells (PBMCs) by using a kinase-specific proteomic approach, and thereafter to investigate the role of the identified kinases in different immune cell subtypes by analyzing biopsies taken from SR- a GvHD patients.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* allo-transplanted * confirmed diagnosis of a GvHD * age ≥ 18 years * peripheral blood samples and biopsies available * written informed consent * ability to understand the nature of the study and the study-related procedures and to comply with them

Exclusion criteria

* age \< 18 years * lack of informed consent * patients that cannot be classified in one of the 2 groups (steroid-refractory, steroid-responsive)

Design outcomes

Primary

Measure	Time frame	Description
Identification of differentially regulated kinases	3 years	Bead-based Kinase Assay enrichment (Knet beads) of PBMC lysates

Secondary

Measure	Time frame	Description
Analysis of protein expression	3 years	Analysis of PBMC lysates by western blot
Analysis of immune cell subtype	3 years	Immunohistochemistry of intestinal biopsies

Outcome results