Trial intelligence / Profile preview

AAT for Pre-Emption of Steroid-Refractory Acute GVHD

NCT03459040Phase 2

Key facts

Status: Completed
Start: Aug 2018
Primary completion: Aug 2020
Countries: 1
Modality: Recombinant Proteins and Enzymes

Drugs: alpha-1-proteinase inhibitor
Conditions: Acute Graft-Versus-Host Disease (aGvHD)

Overview

Phase 2, open-label, single-arm trial of alpha-1-proteinase inhibitor in Acute Graft-Versus-Host Disease (aGvHD). Primary endpoint: Number of High Risk Patients Who Develop Steroid Refractory GVHD at Day 100. Started Aug 2018; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Alpha-1-Antitrypsin
Patients receiving AAT prophylaxis

Who it enrols

High-risk post-HCT patients identified by MAGIC algorithm without active GVHD, infection, or severe organ dysfunction.

Endpoints

Primary

Number of High Risk Patients Who Develop Steroid Refractory GVHDDay 100

Secondary

Number of Participants Alive1 year
Number of Participants With Non-relapse Mortality1 year
Number of Participants With Relapse1 year
Number of Participants With Clinically Relevant GVHD States Grade II-IV GVHD100 days
Number of Participants Achieving Overall ResponseDay 28
Number of Participants With Severe GI GVHD Stage 3 or 4Day 100
Number of Participants With Chronic GVHD Requiring Systemic Steroid Treatment1 year
Number of Participants With Serious Infections1 year

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