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Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone

A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Trial of Alpha 1 - Antitrypsin (AAT) Combined With Corticosteroids vs Corticosteroids Alone for the Treatment of High Risk Acute Graft-versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplant

NCT04167514•CSL Behring

View on ClinicalTrials.gov

Summary

Study CSL964\_5001 will investigate the efficacy of AAT with corticosteroids compared with corticosteroids alone as first line therapy for patients with high-risk acute GVHD

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients 12 years of age or older
•Initial presentation of acute GVHD after allogeneic hematopoietic cell transplantation for any indication
•Any graft or donor source or conditioning intensity
•Clinical diagnosis of acute GVHD requiring systemic therapy with corticosteroids

Exclusion Criteria

•Prior exogenous AAT exposure for GVHD prophylaxis
•Relapsed, progressing, or persistent malignancy
•de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment
•Receiving other drugs for the treatment of GVHD
•Receiving systemic CS for any indication within 7 days before the onset of acute GVHD

Locations (25)

Stanford University

Stanford, California, United States

University of Florida

Gainesville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

IU Hospital

Indianapolis, Indiana, United States

Univ. of Kansas Cancer Center

Westwood, Kansas, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

U-M Medical Center

Ann Arbor, Michigan, United States

Key Dates

Start Date

January 9, 2020

Primary Completion Date

September 11, 2023

Completion Date

June 26, 2024

Last Updated

August 29, 2025

Enrollment

136

ACTUAL participants

Conditions

Graft Versus Host Disease (GVHD)

Interventions

Alpha-1 antitrypsin (AAT)

BIOLOGICAL

Placebo

DRUG

Biomarkers in Predicting Response in Patients With Graft-Versus-Host Disease Undergoing Extracorporeal Photophoresis

NCT01324908

Graft Versus Host Disease (GVHD)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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