Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for GVHD patients: axatilimab faces best available therapy in phase 3 trial

NCT ID NCT06821542

Disease control Sponsor: Incyte Corporation 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times

Summary

This study tests a new drug called axatilimab against the best current treatments for people with chronic graft-versus-host disease (cGVHD), a complication after a stem cell transplant. Participants must be at least 12 years old and have tried at least two prior treatments without success. The goal is to see if axatilimab can better control the disease and improve symptoms.

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

9 people

The number who actually took part.

Started

Jun 2025

Expected to finish

Nov 2032

An estimate. End dates often move.

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: * Age ≥ 12 years at the time of signing the ICF. * 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: * Receipt of more than 1 prior allo-HCT. Prior autologous HCT is allowed. * 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. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic graft versus host disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Chronic graft versus host disease

Contacts and locations

Locations

  • A. Gemelli University Hospital, Catholic University of the Sacred Heart

    Roma, 00168, Italy

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

    Torino, 10126, Italy

  • Algemeen Ziekenhuis Delta

    Roeselare, 08800, Belgium

  • Amsterdam University Medical Center (Amsterdam Umc), Vrije University Medical Center (Vumc)

    Amsterdam, 1081 HV, Netherlands

  • Aou Policlinico Umberto I

    Roma, 00161, Italy

  • Asst Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Attikon Hospital and Cutaneous Lymphoma Clinic-Athens University Medical School

    Athens, 12462, Greece

  • Az Sint-Jan Brugge Av

    Bruges, 08000, Belgium

  • Azienda Ospedale Universita Di Padova

    Padova, 35128, Italy

  • Azienda Ospedaliera Di Rilievo Nazionale (Aorn) 'Antonio Cardarelli'

    Naples, 80131, Italy

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

    Palermo, 90146, Italy

  • Azienda Ospedaliera Papa Giovanni Xxiii

    Bergamo, 24127, Italy

  • Azienda Ospedaliera San Gerardo Di Monza

    Monza, 20900, Italy

  • Azienda Ospedaliera Sant'Orsola Malpighi

    Bologna, 40138, Italy

  • Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica

    Florence, 50134, Italy

  • Azienda Ospedaliero Universitaria Delle Marche Clinica Ematologica

    Ancona, 60126, Italy

  • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - Istituto Di Ematolog

    Bologna, 40138, Italy

  • Azienda Ospedaliero Universitaria Federico Ii Di Napoli

    Naples, 80131, Italy

  • Azienda Policlinico Vittorio Emanuele, Presidio G Rodolico, Universita Di Catania

    Catania, 95125, Italy

  • CHU CAEN

    Caen, 14000, France

  • Cardiff and Vale Nhs Trust - University Hospital of Wales (Uhw)

    Cardiff, CF14 4XW, United Kingdom

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Centre Hospitalier Regional Universitaire (Chru) de Lille - Hopital Claude Huriez

    Lille, 59037, France

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque

    Pessac, 33600, France

  • Centre Hospitalier Universitaire de Nice,Hopital L Archet

    Nice, 06200, France

  • Centro Hospitalar Universitario Lisboa Norte Epe

    Lisbon, 1649-028, Portugal

  • Charite - Universitaetsmedizin Berlin

    Berlin, 10117, Germany

  • Chru Nancy

    Vandœuvre-lès-Nancy, 54511, France

  • Chu D'Amiens-Picardie - Hopital Sud

    Amiens, 80054, France

  • Chu Liege -Centre Hospitalier Universitaire Sart Tilman

    Liège, 04000, Belgium

  • Chu Ucl Namur Site Godinne

    Godinne-mont, 05530, Belgium

  • Chu de Nantes

    Nantes, 44000, France

  • Clinica Ematologica, Dism Azienda Ospedaliero Universitaria

    Udine, 33100, Italy

  • Erasmus Medisch Centrum 1

    Rotterdam, 3015 GD, Netherlands

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 500 05, Czechia

  • Fakultni Nemocnice Ostrava

    Ostrava-poruba, 708 52, Czechia

  • Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Fondazione Ircss Casa Sollievo Della Sofferenza

    San Giovanni Rotondo, 71013, Italy

  • Fondazione Ptv Policlinico Tor Vergata

    Rome, 00133, Italy

  • General Hospital of Athens Evangelismos - Eye Hospital

    Athens, 10676, Greece

  • General Hospital of Thessalonikis George Papanikolaou - Gene and Cell Therapy Center

    Thessaloniki, 57010, Greece

  • Gustave Roussy Cancer Campus Grand Paris- (Institut de Cancerologie Gustave-Roussy)

    Villejuif, 94805, France

  • Haukeland University Hospital

    Bergen, 05021, Norway

  • Helsinki University Central Hospital

    Helsinki, 00029, Finland

  • Hopital Universitaire Robert Debre

    Paris, 75019, France

  • Hopitaux Universitaires de Geneve (Hug) - Centre de Recherche Clinique (Crc)

    Geneva, 01205, Switzerland

  • Hospital Clinic de Barcelona (Hospital Clinic I Provincial)

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario Virgen de La Arrixaca

    El Palmar, 30120, Spain

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria Incliva)

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Maranon (Hgugm)

    Madrid, 28007, Spain

  • Hospital Regional Universitario de Malaga

    Málaga, 29010, Spain

  • Hospital Saint-Louis - Aphp

    Paris, 75010, France

  • Hospital Sant Joan de Deu Barcelona - Children'S Hospital

    Esplugues de Llobregat, 08950, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Infantil Nino Jesus

    Madrid, 28009, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Vall D'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014, Spain

  • Hospital Universitario de Donostia

    SAN Sebasttian, 20014, Spain

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria, 35010, Spain

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041, Spain

  • Institut Catala D Oncologia

    Barcelona, 08908, Spain

  • Institut Catala D'Oncologia Badalona, Hospital Germans Trias I Pujol

    Badalona, 08916, Spain

  • Institut Claudius Regaud Cancer Comprehensive Center - Iuct Oncopole

    Toulouse, 31059, France

  • Institut Paoli Calmettes

    Marseille, 13009, France

  • Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E

    Porto, 4200-072, Portugal

  • Ipo Lisboa Francisco Gentil

    Lisbon, 1099-035, Portugal

  • Irccs - Azienda Ospedaliera Universitaria - Ist San Martino

    Genova, 16132, Italy

  • Irccs Fondazione Policlinico San Matteo

    Pavia, 27100, Italy

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Irccs Ospedale Pediatrico Bambino Gesu

    Rome, 00165, Italy

  • Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) - Ospedale San Raffaele (Hsr) (Istituto

    Milan, 20132, Italy

  • Karolinska Universitetssjukhuset, Centrum For Cellterapi Och Allogen Stamcellstransplantation

    Stockholm, 14186, Sweden

  • King'S College Hospital Nhs Foundation Trust

    London, SE5 9RS, United Kingdom

  • Klinikum Der Johann Wolfgang Goethe-Universitaet

    Frankfurt am Main, 60590, Germany

  • Krankenhaus Der Elisabethinen Linz Gmbh

    Linz, 04020, Austria

  • Leiden University Medical Center (Leids Universitair Medisch Centrum (Lumc))

    Leiden, 2333 ZA, Netherlands

  • Maastricht University Medical Center (Mumc)

    Maastricht, 6229 HX, Netherlands

  • Medical University of Graz

    Graz, 08036, Austria

  • Medizinische Universitaet Innsbruck - Universitaetsklinik Fuer Innere Medizin Iii

    Innsbruck, 06020, Austria

  • Medizinische Universitat Wien, Universitatsklinik Fur Innere Medizin I

    Vienna, 01090, Austria

  • Morelli Hospital

    Reggio Calabria, 89133, Italy

  • New Children'S Hospital, University of Helsinki and Helsinki University Hospital

    Helsinki, 00290, Finland

  • Ospedale Santa Maria Di Ca' Foncello

    Treviso, 31100, Italy

  • Pia Fondazione Cardinale Giovanni Panico Azienda Ospedaliera

    Lecce, 73039, Italy

  • Presidio Ospedaliero Spirito Santo Azienda U.S.L. Pescara

    Pescara, 65124, Italy

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF, United Kingdom

  • Rikshospitalet University Hospital

    Oslo, 00027, Norway

  • Sahlgrenska University Hospital

    Gothenburg, 413 45, Sweden

  • Skanes Universitetssjukhus - Universitetssjukhuset I Lund

    Lund, 221 85, Sweden

  • Ss Antonio & Biagio and C. Arrigo Hospital

    Alessandria, 15121, Italy

  • St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust

    Leeds, LS9 7TF, United Kingdom

  • St. Anna Childrens Hospital

    Vienna, 01090, Austria

  • St. James Hospital

    Dublin, D08 NHY1, Ireland

  • Turku University Hospital

    Turku, 20520, Finland

  • Uniklinik Rwth Aachen Medizinische Klinik Iv

    Aachen, 52074, Germany

  • Universita Degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili Di Brescia

    Brescia, 25123, Italy

  • Universitaetsklinikum Des Saarlandes

    Homburg, 66421, Germany

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitaetsklinikum Halle

    Halle, 06120, Germany

  • Universitaetsklinikum Koeln

    Cologne, 50937, Germany

  • Universitaetsklinikum Muenster

    Münster, 48149, Germany

  • Universitaetsklinikum Schleswig-Holstein, Uksh-Campus Kiel

    Kiel, 24105, Germany

  • Universitaetsmedizin Goettingen

    Göttingen, 37075, Germany

  • Universitair Medisch Centrum Utrecht (Umc Utrecht)

    Utrecht, 3584 CX, Netherlands

  • Universitair Ziekenhuis Leuven

    Leuven, 03000, Belgium

  • Universitat de Valencia - Hospital Universitari I Politecnic La Fe de Valencia

    Valencia, 46026, Spain

  • Universitats-Kinderspital Zurich Eleonorenstiftung

    Zurich, CH-8032, Switzerland

  • Universitatsklinikum Erlangen

    Erlangen, 91054, Germany

  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

    Mainz, 55131, Germany

  • Universitatsspital Zurich

    Zurich, 08091, Switzerland

  • Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert, 01200, Belgium

  • University Clinic Regensburg

    Regensburg, 93053, Germany

  • University Hospital Basel

    Basel, 04031, Switzerland

  • University Hospital Carl Gustav Carus

    Dresden, 01307, Germany

  • University Hospital Leipzig

    Leipzig, 04103, Germany

  • University Hospital of Patras

    RIO Patras, 26504, Greece

  • University Hospital of Ulm, Universitatsklinikum Ulm

    Ulm, 89081, Germany

  • University Hospitals of Leicester Nhs Trust-Leicester Royal Infirmary

    Leicester, LE1 5WW, United Kingdom

  • University Medical Center Groningen

    Groningen, 9713 GZ, Netherlands

  • University of Gothenburg and Queen Silvia Children S Hospital At Sahlgrenska University Hospital

    Gothenburg, 41650, Sweden

  • University of Wuerzburg

    Würzburg, 97080, Germany

  • Uoc Ematologia E Centro Trapianti Midollo Osseo Br, Ospedale Borgo Roma

    Verona, 37134, Italy

  • Uppsala University Hospital

    Uppsala, 75185, Sweden

  • Ustav Hematologie A Krevni Transfuze (Uhkt), the Institute of Hematology and Blood Transfusion (Ihbt

    Prague, 12808, Czechia

More trials for these conditions

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