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New drug duo aims to tame Graft-Versus-Host disease

NCT ID NCT06388564

First seen Nov 01, 2025 · Last updated Jun 22, 2026 · Updated 33 times

Summary

This Phase 2 trial tests whether adding axatilimab to the standard drug ruxolitinib works better for people newly diagnosed with moderate to severe chronic graft-versus-host disease (cGVHD), a complication after stem cell transplant. About 130 participants aged 12 and older will receive the combination or standard care. The main goal is to see if the combination leads to a complete or partial response within 6 months without needing new therapy.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • A.O.U. Citta Della Salute E Della Scienza Di Torino

    Torino, 10126, Italy

  • AZ DELTA

    Roeselare, 08800, Belgium

  • Aou Policlinico S. Orsola-Malpighi

    Bologna, 40138, Italy

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T3N 4N1, Canada

  • Az Sint-Jan Brugge - Oostende Av - Campus Sint-Jan

    Bruges, 08000, Belgium

  • Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii

    Bergamo, 24127, Italy

  • Cambridge University Hospitals Nhs Foundation Trust

    Cambridge, CB2 0QQ, United Kingdom

  • Centre Hospitalier Universitaire (Chu) de Liege

    Liège, 04000, Belgium

  • Chu Sainte-Justine

    Montreal, Quebec, H3T 1C5, Canada

  • City of Hope Medical Center

    Duarte, California, 91010, United States

  • Clatterbridge Cancer Center

    Liverpool, L7 8YA, United Kingdom

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico Di Milano Uo Dermatologia

    Milan, 20122, Italy

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Fred and Pamela Buffett Cancer Center

    Omaha, Nebraska, 68198, United States

  • Froedtert & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • Hospital Clinic Barcelona Main

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Regional Universitario de Malaga

    Málaga, 29011, Spain

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hospital Universitario Virgen de La Arrixaca

    El Palmar, 30120, Spain

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014, Spain

  • Ico Institut Catala D Oncologia

    Granvia de L'hospitalet 199-203, 08908, Spain

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Jessa Ziekenhuis

    Hasselt, 03500, Belgium

  • Klinikum Der Johann Wolfgang Goethe University

    Frankfurt am Main, 60590, Germany

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • Md Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ospedale Pediatrico Bambino Gesu Irccs

    Rome, 00165, Italy

  • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

    Rome, 00168, Italy

  • Princess Margaret Cancer Centre - University Health Network

    Toronto, Ontario, M5G 2M9, Canada

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH, United Kingdom

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF, United Kingdom

  • Smilow Cancer Center-Yale

    New Haven, Connecticut, 06510, United States

  • St James University Hospital

    Leeds, LS9 7TF, United Kingdom

  • Stanford Cancer Center

    Stanford, California, 94305, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • The University of Chicago Medicine

    Chicago, Illinois, 60637, United States

  • Universitaetsklinikum Jena

    Jena, 07747, Germany

  • Universitaetsklinikum Regensburg

    Regensburg, 93053, Germany

  • Universitair Ziekenhuis (Uz) Leuven

    Leuven, 03000, Belgium

  • Universitair Ziekenhuis Antwerpen (Uza)

    Edegem, 02650, Belgium

  • Universitaire Ziekenhuis Leuven - Gasthuisberg

    Leuven, 03000, Belgium

  • Universitatklinikum Freiburg

    Freiburg I. Breisgau, 79106, Germany

  • Universitatsklinikum Hamburg Eppendorf

    Hamburg, 20251, Germany

  • University Hospital Mannheim

    Mannheim, 68167, Germany

  • University Hospital of Wales

    Cardiff, CF14 4XW, United Kingdom

  • University of California-Los Angeles Medl Cntr-Oncology Center Bowyer Clinic

    Los Angeles, California, 90095, United States

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045, United States

  • University of Maryland-Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Vancouver General Hospital

    Vancouver, V5Z1M9, Canada

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medicine

    New York, New York, 10021, United States

What this could mean

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

Active substance

axatilimab and ruxolitinib

What this could lead to

If successful, this combination could offer a more effective first-line treatment for chronic graft-versus-host disease, potentially reducing the need for long-term steroids.

What could go wrong

This is an early Phase 2 trial with only 130 participants, so results may not apply to everyone. Side effects from the drug combination are possible, and the study is not yet complete.

Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans Syndrome chronic graft versus host disease

As listed by the trial registrant

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