Trial intelligence / Profile preview

Itacitinib Monotherapy for Low Risk GVHD

NCT03846479Phase 2

Key facts

Status: Completed
Start: Mar 2019
Primary completion: May 2021
Countries: 1
Modality: Small Molecules

Drugs: itacitinib
Conditions: Acute Graft-Versus-Host Disease (aGVHD)

Overview

Phase 2, open-label, single-arm trial of itacitinib in Acute Graft-Versus-Host Disease (aGVHD). Primary endpoints: Overall Response Rate at 28 days and Number of Participants Who Developed Steroid Refractory GVHD at 28 days. Started Mar 2019; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Itacitinib Monotherapy
Single arm receiving itacitinib 200 mg daily

Who it enrols

Newly diagnosed Minnesota standard risk, Ann Arbor 1 acute GVHD patients aged 12-75 who have not received prior systemic treatment.

Endpoints

Primary

Overall Response Rate28 days
Number of Participants Who Developed Steroid Refractory GVHD28 days

Secondary

Number of Participants With Serious Infections90 days
Overall Survival1 year
Non-relapse Mortality1 year
Relapse1 year
Chronic GVHD1 year
Cumulative Steroid Dose28 days

Beyond the preview

Go deeper on NCT03846479.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT03846479.