Trial intelligence / Profile preview

Itacitinib to Prevent Graft Versus Host Disease

NCT04859946Phase 2

Key facts

Status: Active, not recruiting
Start: Jan 2022
Primary completion: Apr 2027
Countries: 1
Sponsor: University of Texas MD Anderson Cancer Center
Modality: Small Molecules

Drugs: itacitinib
Conditions: graft-versus-host disease (GVHD)

Overview

Phase 2, open-label, single-arm trial of itacitinib in graft-versus-host disease (GVHD), sponsored by University of Texas MD Anderson Cancer Center. Primary endpoint: Incidence of acute grade 2-4 graft versus host disease at 100 days. Started Jan 2022; status: active, not recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Supportive care (itacitinib)
Conditioning followed by ASCT, then GVHD prophylaxis with cyclophosphamide, itacitinib, and tacrolimus.

Who it enrols

Adult patients 18-70 years with hematological disorders undergoing allogeneic stem cell transplant, with adequate organ function and matched donor, excluding those with severe cardiac disease, active hepatitis B/C, or unresolved prior toxicities.

Endpoints

Primary

Incidence of acute grade 2-4 graft versus host disease100 days

Secondary

GVHD-free relapse-free survival1 year
Time to neutrophil and platelet engraftment365 days
Overall survival365 days
Progression-free survival365 days
Time to relapse365 days
Non-relapse mortality365 days
Cumulative incidence of limited, extensive, and moderate to severe chronic GVHD365 days
Incidence of adverse events365 days

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