A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
NCT ID: NCT06585774
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
240 participants
INTERVENTIONAL
2025-01-21
2030-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Axatilimab + Corticosteroids
Axatilimab and Corticosteroids at the protocol-defined dose.
INCA034176
IV infusion
Corticosteroids
Oral/IV Infusion
Placebo + Corticosteroids
Matching placebo and Corticosteroids at the protocol-defined dose.
Placebo
IV infusion
Corticosteroids
Oral/IV Infusion
Interventions
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INCA034176
IV infusion
Placebo
IV infusion
Corticosteroids
Oral/IV Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy.
* History of allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible.
* Adequate hematologic function with ANC ≥ 0.5 × 109/L independent of growth factors for at least 7 days prior to study entry.
* Willingness to avoid pregnancy or fathering children.
Exclusion Criteria
* Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.
* Received more than 7 days of systemic corticosteroid treatment for cGVHD or unable to begin a prednisone dose ≥ 1.0 mg/kg per day (or methylprednisolone equivalent) for cGVHD.
* Received previous systemic treatment for cGVHD, including extracorporeal photopheresis.
* Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1.
* Prior treatment with CSF-1R targeted therapies.
* Active, uncontrolled bacterial, fungal, parasitic, or viral infection.
* Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-HCT was performed, including DLIs for the treatment of molecular relapse.
* History of acute or chronic pancreatitis.
* Active symptomatic myositis.
* History or current diagnosis of cardiac disease indicating significant risk of safety for participation in the study, such as uncontrolled or significant cardiac disease.
* Severe renal impairment, that is, estimated CrCl \< 30 mL/min measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or endstage renal disease on dialysis.
* Impaired liver function, defined as total bilirubin \> 1.5 × ULN and/or ALT and AST \> 3 × ULN in participants with no evidence of liver cGVHD.
* Pregnant or breastfeeding.
12 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Albert Assad, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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University of California San Diego Medical Center, Moores Cancer Center
La Jolla, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Childrens National Hospital
Washington D.C., District of Columbia, United States
Orlando Health Cancer Institute Downtown Orlando
Orlando, Florida, United States
Memorial Cancer Institute
Pembroke Pines, Florida, United States
Emory University-Winship Cancer Institute
Atlanta, Georgia, United States
University of Illinois
Chicago, Illinois, United States
The University of Kansas Cancer Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Corewell Health Hematology Oncology
Grand Rapids, Michigan, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Rutgers Cancer Institute of Nj
New Brunswick, New Jersey, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Oregon Health and Science University
Portland, Oregon, United States
Jefferson University Hospitals
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health Upstate
Greenville, South Carolina, United States
Baptist Cancer Center
Memphis, Tennessee, United States
Texas Transplant Institute
San Antonio, Texas, United States
Intermountain Blood and Marrow Transplant
Salt Lake City, Utah, United States
West Virginia University Cancer Institute
Morgantown, West Virginia, United States
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Austin Health Medical Oncology and Clinical Haematology
Heidelberg, Victoria, Australia
Landeskrankenhaus Universitatsklinikum Graz
Graz, , Austria
Innsbruck University Hospital
Innsbruck, , Austria
Ordensklinikum Linz Gmbh Elisabethinen
LINZ CET, , Austria
St. Anna Childrens Hospital
Vienna, , Austria
Alberta'S Children Hospital
Calgary, Alberta, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Hospital Maisonneuve Rosemont
Montreal, Quebec, Canada
Vancouver General Hospital
Vancouver, , Canada
Rigshospitalet
Copenhagen, , Denmark
Chu Amiens Picardie - Hopital Sud
Amiens, , France
Hopitaux de Brabois
Nancy, , France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes, , France
Chu de Nice - Hospital L Archet
Nice, , France
Hospital Saint Louis
Paris, , France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
Toulouse, , France
University Medical Center Rwth Aachen
Aachen, , Germany
Charite Universitatsmedizin Berlin
Berlin, , Germany
Universitaetsklinikum Bonn, University Hospital Bonn
Bonn, , Germany
University Clinic Carl Gustav Carus Technical University Dresden
Dresden, , Germany
University Hospital Duesseldorf
Düsseldorf, , Germany
Universitaetsklinikum Erlangen
Erlangen, , Germany
Universitatsklinikum Essen
Essen, , Germany
Universitatsklinikum Halle (Saale)
Halle, , Germany
University Hospital Schleswig-Holstein Campus Kiel
Kiel, , Germany
Universitatsklinikum Leipzig
Leipzig, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, , Germany
Klinikum Der Philipps-Universitaet Marburg
Marburg, , Germany
Universitatsklinikum Munster
Münster, , Germany
St. James Hospital
Dublin, , Ireland
Azienda Ospedaliero-Universitaria Di Alessandria Ss.Antonio E Biagio E Cesare Arrigo
Alessandria, , Italy
Azienda Ospedaliero Universitaria Delle Marche
Ancona, , Italy
Asst Degli Spedali Civili Di Brescia
Brescia, , Italy
Irccs Azienda Ospedaliera Universitaria San Martino
Genova, , Italy
Ospedale San Raffaele - Milano
Milan, , Italy
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Napoli, , Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, , Italy
Irccs Fondazione Policlinico San Matteo
Pavia, , Italy
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Reggio Calabria, , Italy
Azienda Policlinico Umberto 1 Universita Sapienza Di Roma
Rome, , Italy
Ospedale Pediatrico Bambino Gesu Irccs
Rome, , Italy
I.R.C.C.S. Casa Sollievo Della Sofferenza
San Giovanni Rotondo, , Italy
Azienda Ospedaliera Card. G. Panico
Tricase, , Italy
Centro Ricerche Cliniche Di Verona
Verona, , Italy
Fujita Health University Hospital
Aichi, , Japan
Anjo Kosei Hospital
Aichi-ken, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
Kobe City Medical Center General Hospital
Hyōgo, , Japan
Tokai University Hospital
Isehara Kanagawa, , Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto Kumamoto, , Japan
Gunma Saiseikai Maebashi Hospital
Maebashi, , Japan
Tohoku University Hospital
Miyagi, , Japan
Okayama University Hospital
Okayama-ken, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Hokkaido University Hospital
Sapporo Hokkaido, , Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Tokyo, , Japan
Amsterdam University Medical Centre
Amsterdam, , Netherlands
Hospital General Universitario Vall D Hebron
Barcelona, , Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Universitario Donostia
Donostia / San Sebastian, , Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Puerta de Hierro
Majadahonda, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Universitari I Politecnic La Fe
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
University College London Hospitals (Uclh)
London, , United Kingdom
Manchester University Nhs Foundation Trust
Manchester, , United Kingdom
Nottingham University Hospitals
Nottingham, , United Kingdom
Plymouth Hospitals Nhs Trust
Plymouth, , United Kingdom
Countries
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Central Contacts
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Related Links
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A study to evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Other Identifiers
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2023-510292-65-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCA34176-357
Identifier Type: -
Identifier Source: org_study_id