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A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD)

Chronic Graft-versus-host-disease Clinical Trial

Official title:
A Pilot Study of INCB039110 (Itacitinib) for the Treatment of Steroid Refractory Chronic Graft-Versus-Host Disease

Clinical Trial Summary

This study is being done in patients who have been receiving corticosteroids or other immunosuppressive therapies for the treatment of cGVHD for at least 6 months. The purpose of this study is to find out if itacitinib in combination with corticosteroids or other immunosuppressive therapies is safe and effective in people with cGVHD.

Clinical Trial Description

Graft versus host disease remains a major hurdle to improve allogeneic hematopoietic stem cell transplantation outcome, with cGVHD being associated with decreased quality of life. Suppression of the immune system with corticosteroids forms the basis of first-line therapy for management of GVHD, but sustained responses are usually seen in less than 50 percent of patients and there is no standard second- or third-line treatment for steroid refractory cGVHD. Identification of novel therapeutic targets are needed to improve outcomes. Therapeutic potential has been shown by a JAK inhibitor in the treatment of steroid refractory GVHD. Itacitinib is a novel, selective inhibitor of the JAK family of protein tyrosine kinases and will be studied here in patients with steroid refractory cGVHD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04200365
Study type Interventional
Source SCRI Development Innovations, LLC
Contact
Status Terminated
Phase Phase 2
Start date June 5, 2020
Completion date September 7, 2023
View Details
See also
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