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

Completed · Phase 3 · Has a placebo group

Conditions studied: Graft Versus Host Disease (GVHD)

In brief

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

Key facts

Study ID

NCT04167514

Run by

CSL Behring

People needed

136

Starts

2020-01-09

Expected to finish

2024-06-26

Last updated by the study team

2026-07-28

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Karmanos Cancer Center — Detroit, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• MSKCC — New York, New York, United States
• Levine Cancer Center — Charlotte, North Carolina, United States
• Duke — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State Univ.Medical Center — Columbus, Ohio, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Center for Gene Therapy — Houston, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Virginia Commonwealth Univ. — Richmond, Virginia, United States
• Fred Hutchinson Clinic — Seattle, Washington, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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