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Can a lung drug stop transplant rejection? new trial tests Alpha-1 antitrypsin for GVHD

NCT ID NCT03805789

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This study tested whether a drug called alpha-1 antitrypsin (AAT) can prevent graft-versus-host disease (GVHD) in people receiving stem cell transplants for blood cancers. GVHD occurs when donor immune cells attack the patient's body. The trial enrolled 222 participants and compared AAT to a placebo. The goal was to see if AAT could delay or prevent severe GVHD and improve outcomes.

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)
What this could lead to
If it works, this could offer a new way to prevent graft-versus-host disease, a common and dangerous complication of stem cell transplants.
What could go wrong
This is a mid-stage trial with 222 participants, so results are not yet conclusive. The treatment may not reduce GVHD risk or could cause side effects like allergic reactions.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

222 people

The number who actually took part.

Started

Mar 2019

Finished

Mar 2026

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: * • Male or female participants, \>=12 years of age (\>= 18 years of age for participants at German sites only), undergoing HCT for hematological malignancies, including leukemia, lymphoma, multiple myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms. * • Planned myeloablative conditioning regimen. * • Participants must have a related or unrelated donor as follows: * \- Related donor must be a 6 / 6 match for human leukocyte antigen (HLA)-A, -B, at intermediate (or higher) resolution, and -DR beta 1 (DRB1) at high resolution using deoxyribonucleic acid (DNA)-based typing. * \- Unrelated donor must be 7 / 8 or 8 / 8 match for HLA-A, -B, and -C at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing. Exclusion Criteria: * • Prior autologous or allogeneic HCT. * • T cell depleted transplant or planned use of anti-T cell antibody therapy either ex vivo or in vivo (ie, anti thymocyte globulin \[ATG\], alemtuzumab) for GVHD prophylaxis. * • Planned umbilical cord blood transplant. * • Planned use of cyclophosphamide after HCT for GVHD prophylaxis. * • Planned haploidentical donor.

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid cell neoplasm acute graft versus host disease prevention target

As listed by the trial registrant

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

Acute-graft-versus-host disease

Contacts and locations

Locations

  • Aichi Medical Center Nagoya Daiichi Hospital

    Nagoya, 4538511, Japan

  • Anjo Kosei Hospital

    Anjo-shi, 4668602, Japan

  • Ankara Abdurrahman Yurtaslan

    Ankara, 06200, Turkey (Türkiye)

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

    Calabria, 89133, Italy

  • Hiroshima University Kasumi Campus

    Hiroshima, 7348551, Japan

  • Hokkaido University Hospital

    Sapporo, 0608648, Japan

  • HonorHealth Scottsdale Shea Medical Center

    Scottsdale, Arizona, 85258, United States

  • Hospital Universitario Valle de Hebron

    Barcelona, 08035, Spain

  • INJE University Haeundae Paik Hospital

    Busan, 48108, South Korea

  • Johns Hopkins Hospital

    St. Petersburg, Florida, 33701, United States

  • Marqués de Valdecilla University Hospital

    Barcelona, 39008, Spain

  • Nagoya University Hospital

    Nagoya, 4668550, Japan

  • Okayama University Hospital

    Okayama, 71008558, Japan

  • Osaka International Cancer Institute

    Osaka, 5418567, Japan

  • Osaka Metropolitan University Hospital

    Osaka, 5458586, Japan

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Royal Brisbane and Women's Hospital

    Herston, Queenland, 4029, Australia

  • Salamanca University Hospital

    Salamanca, 37007, Spain

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • The University of Texas-MD Anderson Cancer Center

    San Antonio, Texas, 77030, United States

  • Tokyo Metropolitan Komagome Hospital

    Bunkyō City, 1138677, Japan

  • Turgut Ozal Medicine Center

    Battalgazi, 44280, Turkey (Türkiye)

  • Uniklinik Köln

    Cologne, 50937, Germany

  • University Hospital Catania

    Calabria, Catania, 95123, Italy

  • University Hospital Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109, United States

  • University of Utah Primary Children's Hospital

    Salt Lake City, Utah, 84113, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22903, United States

More trials for these conditions

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