Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Efficacy and Tolerability of Entospletinib in Combination With Systemic Corticosteroids as First-Line Therapy in Adults With Chronic Graft Versus Host Disease (cGVHD)

Protocol: OSU-15285

Full Title

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Tolerability of Entospletinib, a Selective SYK Inhibitor, in Combination with Systemic Corticosteroids as First-Line Therapy in Subjects with Chronic Graft Versus Host Disease (cGVHD)

Purpose

This study will evaluate the effect of entospletinib on the best overall response rate in

adults with chronic graft versus host disease (cGVHD) who are currently receiving systemic

corticosteroids as first-line therapy for cGVHD.

Are you eligible?

Inclusion Criteria:

Willing and able to provide written informed consent

Male or non-pregnant, non-lactating, females

Newly diagnosed cGVHD defined by:

At least 100 days after receiving any allogeneic hematopoietic stem cell

transplant AND

Receiving a new course of systemic corticosteroids (1.0 mg/kg/day or prednisone

equivalent) as first-line cGVHD therapy at least 1 day and no more than 21 days

prior to first dose of ENTO/Placebo AND

Moderate to severe cGVHD as assessed by NIH cGVHD Diagnosis and Staging Criteria

(NCDSC) with at least three organ systems involved OR one organ system with a

score of 2 OR lung organ score = 1

Individuals who have undergone transplant for hematologic malignancy are required to

be in complete remission.

Have either a normal ECG or one with abnormalities that are considered clinically

insignificant by the investigator in consultation with the Sponsor

Exclusion Criteria:

Uncontrolled infection within 4 weeks prior to randomization

History of the following therapies in the post-transplant period:

B cell depleting biologic agents

CD19 CAR-T cells based therapies

BTK/SYK/JAK/PI3K inhibitors

Phototherapy-unless administered for acute GVHD

Treatment of cGVHD with anti-thymocyte globulins (ATG), or campath within 60 days of

screening visit unless used for treatment of acute GVHD

Severe organ dysfunction manifested during screening period:

Requiring supplemental oxygen at more than 2 L/min

Uncontrolled arrhythmia or heart failure