A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy
NCT ID: NCT06821542
Last Updated: 2025-09-08
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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ACTIVE_NOT_RECRUITING
PHASE3
9 participants
INTERVENTIONAL
2025-06-04
2032-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Axatilimab
Axatilimab at the protocol-defined dose.
INCA034176
IV infusion
Best available Treatment (BAT)
Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Best Available Therapy (BAT)
Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Interventions
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INCA034176
IV infusion
Best Available Therapy (BAT)
Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active, moderate to severe cGVHD, requiring systemic immune suppression.
* Participants with refractory or recurrent cGVHD who have received at least 2 lines of systemic therapy, including corticosteroids and ruxolitinib.
* Concomitant use of systemic corticosteroids is allowed. Participants on systemic corticosteroids must be on a stable dose of corticosteroids for at least 2 weeks prior to C1D1. Topical and inhaled corticosteroid agents are allowed.
* Participants must accept to be treated with one of the following BAT options on C1D1: CNI (cyclosporine or tacrolimus), ECP, MMF, an mTOR inhibitor (everolimus or sirolimus), rituximab, pentostatin, proteasome inhibitors, imatinib, or ibrutinib.
* 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.
Exclusion Criteria
* Evidence of relapse of hematologic disease or treatment for relapse after the allo-SCT was performed, including DLI for the treatment of molecular relapse. Note: Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible.
* Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1.
* Severe renal impairment, that is, estimated creatinine clearance \< 30 mL/min measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or end-stage 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.
* History of acute or chronic pancreatitis.
* Active, symptomatic myositis.
* 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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Incyte Medical Monitor
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Irccs Ospedale Pediatrico Bambino Gesu
Rome, , Italy
Irccs Istituto Clinico Humanitas
Rozzano, , Italy
Fondazione Ircss Casa Sollievo Della Sofferenza
San Giovanni Rotondo, , Italy
A.O.U. Citta Della Salute E Della Scienza Di Torino
Torino, , Italy
Ospedale Santa Maria Di Ca' Foncello
Treviso, , Italy
Medical University of Graz
Graz, , Austria
Medizinische Universitaet Innsbruck - Universitaetsklinik Fuer Innere Medizin Iii
Innsbruck, , Austria
Krankenhaus Der Elisabethinen Linz Gmbh
Linz, , Austria
Medizinische Universitat Wien, Universitatsklinik Fur Innere Medizin I
Vienna, , Austria
St. Anna Childrens Hospital
Vienna, , Austria
Az Sint-Jan Brugge Av
Bruges, , Belgium
Chu Ucl Namur Site Godinne
Godinne-mont, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Chu Liege -Centre Hospitalier Universitaire Sart Tilman
Liège, , Belgium
Algemeen Ziekenhuis Delta
Roeselare, , Belgium
Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, , Belgium
Fakultni Nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni Nemocnice Ostrava
Ostrava-poruba, , Czechia
Ustav Hematologie A Krevni Transfuze (Uhkt), the Institute of Hematology and Blood Transfusion (Ihbt
Prague, , Czechia
Helsinki University Central Hospital
Helsinki, , Finland
New Children'S Hospital, University of Helsinki and Helsinki University Hospital
Helsinki, , Finland
Turku University Hospital
Turku, , Finland
Chu D'Amiens-Picardie - Hopital Sud
Amiens, , France
CHU CAEN
Caen, , France
Centre Hospitalier Regional Universitaire (Chru) de Lille - Hopital Claude Huriez
Lille, , France
Institut Paoli Calmettes
Marseille, , France
Chu de Nantes
Nantes, , France
Centre Hospitalier Universitaire de Nice,Hopital L Archet
Nice, , France
Hospital Saint-Louis - Aphp
Paris, , France
Hopital Universitaire Robert Debre
Paris, , France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque
Pessac, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Henri Becquerel
Rouen, , France
Institut Claudius Regaud Cancer Comprehensive Center - Iuct Oncopole
Toulouse, , France
Chru Nancy
Vandœuvre-lès-Nancy, , France
Gustave Roussy Cancer Campus Grand Paris- (Institut de Cancerologie Gustave-Roussy)
Villejuif, , France
Uniklinik Rwth Aachen Medizinische Klinik Iv
Aachen, , Germany
Charite - Universitaetsmedizin Berlin
Berlin, , Germany
Universitaetsklinikum Koeln
Cologne, , Germany
University Hospital Carl Gustav Carus
Dresden, , Germany
Universitatsklinikum Erlangen
Erlangen, , Germany
Klinikum Der Johann Wolfgang Goethe-Universitaet
Frankfurt am Main, , Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitaetsmedizin Goettingen
Göttingen, , Germany
Universitaetsklinikum Halle
Halle, , Germany
Universitaetsklinikum Des Saarlandes
Homburg, , Germany
Universitaetsklinikum Schleswig-Holstein, Uksh-Campus Kiel
Kiel, , Germany
University Hospital Leipzig
Leipzig, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
University Clinic Regensburg
Regensburg, , Germany
University Hospital of Ulm, Universitatsklinikum Ulm
Ulm, , Germany
University of Wuerzburg
Würzburg, , Germany
General Hospital of Athens Evangelismos - Eye Hospital
Athens, , Greece
Attikon Hospital and Cutaneous Lymphoma Clinic-Athens University Medical School
Athens, , Greece
University Hospital of Patras
RIO Patras, , Greece
General Hospital of Thessalonikis George Papanikolaou - Gene and Cell Therapy Center
Thessaloniki, , Greece
St. James Hospital
Dublin, , Ireland
Ss Antonio & Biagio and C. Arrigo Hospital
Alessandria, , Italy
Azienda Ospedaliero Universitaria Delle Marche Clinica Ematologica
Ancona, , Italy
Azienda Ospedaliera Papa Giovanni Xxiii
Bergamo, , Italy
Azienda Ospedaliera Sant'Orsola Malpighi
Bologna, , Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - Istituto Di Ematolog
Bologna, , Italy
Universita Degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili Di Brescia
Brescia, , Italy
Azienda Policlinico Vittorio Emanuele, Presidio G Rodolico, Universita Di Catania
Catania, , Italy
Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica
Florence, , Italy
Irccs - Azienda Ospedaliera Universitaria - Ist San Martino
Genova, , Italy
Pia Fondazione Cardinale Giovanni Panico Azienda Ospedaliera
Lecce, , Italy
Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico
Milan, , Italy
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) - Ospedale San Raffaele (Hsr) (Istituto
Milan, , Italy
Asst Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Azienda Ospedaliera San Gerardo Di Monza
Monza, , Italy
Azienda Ospedaliero Universitaria Federico Ii Di Napoli
Naples, , Italy
Azienda Ospedaliera Di Rilievo Nazionale (Aorn) 'Antonio Cardarelli'
Napoli, , Italy
Azienda Ospedale Universita Di Padova
Padua, , Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, , Italy
Irccs Fondazione Policlinico San Matteo
Pavia, , Italy
Presidio Ospedaliero Spirito Santo Azienda U.S.L. Pescara
Pescara, , Italy
Morelli Hospital
Reggio Calabria, , Italy
Aou Policlinico Umberto I
Roma, , Italy
A. Gemelli University Hospital, Catholic University of the Sacred Heart
Roma, , Italy
Fondazione Ptv Policlinico Tor Vergata
Rome, , Italy
Clinica Ematologica, Dism Azienda Ospedaliero Universitaria
Udine, , Italy
Uoc Ematologia E Centro Trapianti Midollo Osseo Br, Ospedale Borgo Roma
Verona, , Italy
Amsterdam University Medical Center (Amsterdam Umc), Vrije University Medical Center (Vumc)
Amsterdam, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Leiden University Medical Center (Leids Universitair Medisch Centrum (Lumc))
Leiden, , Netherlands
Maastricht University Medical Center (Mumc)
Maastricht, , Netherlands
Erasmus Medisch Centrum 1
Rotterdam, , Netherlands
Universitair Medisch Centrum Utrecht (Umc Utrecht)
Utrecht, , Netherlands
Haukeland University Hospital
Bergen, , Norway
Rikshospitalet University Hospital
Oslo, , Norway
Ipo Lisboa Francisco Gentil
Lisbon, , Portugal
Centro Hospitalar Universitario Lisboa Norte Epe
Lisbon, , Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E
Porto, , Portugal
Institut Catala D'Oncologia Badalona, Hospital Germans Trias I Pujol
Badalona, , Spain
Hospital Universitario Vall D'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona (Hospital Clinic I Provincial)
Barcelona, , Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, , Spain
Institut Catala D Oncologia
Barcelona, , Spain
Hospital Clinico Universitario Virgen de La Arrixaca
El Palmar, , Spain
Hospital Sant Joan de Deu Barcelona - Children'S Hospital
Esplugues de Llobregat, , Spain
Hospital Universitario Virgen de Las Nieves
Granada, , Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, , Spain
Hospital General Universitario Gregorio Maranon (Hgugm)
Madrid, , Spain
Hospital Universitario Infantil Nino Jesus
Madrid, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario de Donostia
SAN Sebasttian, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria Incliva)
Valencia, , Spain
Universitat de Valencia - Hospital Universitari I Politecnic La Fe de Valencia
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Sahlgrenska University Hospital
Gothenburg, , Sweden
University of Gothenburg and Queen Silvia Children S Hospital At Sahlgrenska University Hospital
Gothenburg, , Sweden
Skanes Universitetssjukhus - Universitetssjukhuset I Lund
Lund, , Sweden
Karolinska Universitetssjukhuset, Centrum For Cellterapi Och Allogen Stamcellstransplantation
Stockholm, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
University Hospital Basel
Basel, , Switzerland
Hopitaux Universitaires de Geneve (Hug) - Centre de Recherche Clinique (Crc)
Geneva, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
Universitats-Kinderspital Zurich Eleonorenstiftung
Zurich, , Switzerland
Cardiff and Vale Nhs Trust - University Hospital of Wales (Uhw)
Cardiff, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust
Leeds, , United Kingdom
University Hospitals of Leicester Nhs Trust-Leicester Royal Infirmary
Leicester, , United Kingdom
King'S College Hospital Nhs Foundation Trust
London, , United Kingdom
Countries
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Related Links
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A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy
Other Identifiers
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2024-518973-32-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCA034176-355
Identifier Type: -
Identifier Source: org_study_id
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