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

NCT ID NCT04167514

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

136 people

The number who actually took part.

Started

Jan 2020

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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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

More trials for these conditions

Other studies related to the condition(s) this trial covers.