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Can a lung protein tame severe graft-versus-host disease?

NCT ID NCT04167514

Completed Disease control Sponsor: CSL Behring Source: ClinicalTrials.gov ↗

First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This phase 3 trial investigates whether adding alpha-1 antitrypsin (AAT) to standard corticosteroid therapy improves outcomes for people with high-risk acute graft-versus-host disease (GVHD) after a stem cell transplant. Participants receive either AAT plus steroids or a placebo plus steroids. The main goal is to see if the combination leads to a better overall response at day 28 without needing stronger treatment.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
alpha-1 antitrypsin (AAT) given intravenously plus corticosteroids
What this could lead to
If effective, this combination could become a new first-line treatment for high-risk acute GVHD, potentially improving response rates and reducing the need for additional therapies.
What could go wrong
This is an early-phase trial with a relatively small number of participants, so results may not confirm benefit. AAT is generally well-tolerated, but infusion reactions or allergic responses are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

acute graft versus host disease graft versus host disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GRAFT VERSUS HOST DISEASE (GVHD)

Contacts and locations

Locations

  • Center for Gene Therapy

    Houston, Texas, 77030, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44124, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke

    Durham, North Carolina, 27705, United States

  • Emory University

    Atlanta, Georgia, 30322-1059, United States

  • Fred Hutchinson Clinic

    Seattle, Washington, 98109, United States

  • IU Hospital

    Indianapolis, Indiana, 46202, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Karmanos Cancer Center

    Detroit, Michigan, 48201, United States

  • Levine Cancer Center

    Charlotte, North Carolina, 28204, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • MSKCC

    New York, New York, 10065, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Northside Hospital

    Atlanta, Georgia, 30342, United States

  • Ohio State Univ.Medical Center

    Columbus, Ohio, 43210, United States

  • Stanford University

    Stanford, California, 94305, United States

  • U-M Medical Center

    Ann Arbor, Michigan, 48109-0312, United States

  • Univ. of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Florida

    Gainesville, Florida, 32608, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Wisconsin

    Madison, Wisconsin, 53705, United States

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Virginia Commonwealth Univ.

    Richmond, Virginia, 23298, United States

  • Washington University

    St Louis, Missouri, 63110, United States

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