Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (AXemplify-357)
Led by Incyte Corporation · Updated on 2026-06-01
240
Participants Needed
122
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
CONDITIONS
Brief Title
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ≥ 12 years of age at the time of informed consent.
- 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.
You will not qualify if you...
- Received more than 1 prior allo-HCT. Prior autologous HCT is allowed.
- 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.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 122 locations
1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of California San Diego Medical Center, Moores Cancer Center
La Jolla, California, United States, 92037
Actively Recruiting
3
University of Southern California
Los Angeles, California, United States, 90089
Actively Recruiting
4
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
5
Childrens National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
6
Miami Cancer Institute
Miami, Florida, United States, 33176
Actively Recruiting
7
Orlando Health Cancer Institute Downtown Orlando
Orlando, Florida, United States, 32806
Actively Recruiting
8
Memorial Cancer Institute
Pembroke Pines, Florida, United States, 33026
Actively Recruiting
9
Emory University-Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
10
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
11
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
12
The University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
13
John Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
14
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
15
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
16
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
17
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
18
Corewell Health Hematology Oncology
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
19
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
20
Rutgers Cancer Institute of Nj
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
21
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
22
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Actively Recruiting
23
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
24
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
25
Jefferson University Hospitals
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
26
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
27
Prisma Health Upstate
Greenville, South Carolina, United States, 29615
Actively Recruiting
28
Baptist Cancer Center
Memphis, Tennessee, United States, 38120
Actively Recruiting
29
St David'S South Austin Medical Center
Austin, Texas, United States, 78704
Actively Recruiting
30
Texas Transplant Institute
San Antonio, Texas, United States, 78229
Actively Recruiting
31
Intermountain Blood and Marrow Transplant
Salt Lake City, Utah, United States, 84143
Actively Recruiting
32
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
33
West Virginia University Cancer Institute
Morgantown, West Virginia, United States, 26506
Actively Recruiting
34
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 02050
Actively Recruiting
35
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 05000
Actively Recruiting
36
Austin Health Medical Oncology and Clinical Haematology
Heidelberg, Victoria, Australia, 03084
Actively Recruiting
37
Landeskrankenhaus Universitatsklinikum Graz
Graz, Austria, A-8036
Actively Recruiting
38
Innsbruck University Hospital
Innsbruck, Austria, A-6020
Actively Recruiting
39
Ordensklinikum Linz Gmbh Elisabethinen
LINZ CET, Austria, A-4020
Actively Recruiting
40
Akh Und Medizinische Universitat Wien Universitatsklinik Fur Innere Medizin I
Vienna, Austria, 01090
Actively Recruiting
41
St. Anna Childrens Hospital
Vienna, Austria, 01090
Actively Recruiting
42
Alberta'S Children Hospital
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
43
Stollery Children'S Hospital
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
44
Bc Children'S Hospital
Vancouver, British Columbia, Canada, V6G1R8
Actively Recruiting
45
Queen Elizabeth Ii Health Sciences Centre
Halifax, Nova Scotia, Canada
Actively Recruiting
46
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
47
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
48
Hospital Maisonneuve Rosemont
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
49
Vancouver General Hospital
Vancouver, Canada, V5Z1M9
Actively Recruiting
50
Rigshospitalet
Copenhagen, Denmark, 02100
Actively Recruiting
51
Chu Amiens Picardie - Hopital Sud
Amiens, France, 80054
Actively Recruiting
52
Institut Paoli Calmettes
Marseille, France, 13273
Actively Recruiting
53
Hopitaux de Brabois
Nancy, France, 54511
Actively Recruiting
54
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes, France, 44903
Actively Recruiting
55
Chu de Nice - Hospital L Archet
Nice, France, 06202
Actively Recruiting
56
Hospital Saint Louis
Paris, France, 75010
Actively Recruiting
57
Hospital Saint Antoine
Paris, France, 75012
Actively Recruiting
58
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69310
Actively Recruiting
59
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
Toulouse, France, 31059
Actively Recruiting
60
University Medical Center Rwth Aachen
Aachen, Germany, D-52074
Actively Recruiting
61
Charite Universitatsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
62
Universitaetsklinikum Bonn, University Hospital Bonn
Bonn, Germany, 53127
Actively Recruiting
63
University Clinic Carl Gustav Carus Technical University Dresden
Dresden, Germany, 01307
Actively Recruiting
64
University Hospital Duesseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
65
Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
66
Universitatsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
67
Universitatsklinikum Halle (Saale)
Halle, Germany, 06120
Actively Recruiting
68
University Hospital Schleswig-Holstein Campus Kiel
Kiel, Germany, 24105
Actively Recruiting
69
Universitatsklinikum Leipzig
Leipzig, Germany, 04103
Actively Recruiting
70
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, Germany, 55131
Actively Recruiting
71
Klinikum Der Philipps-Universitaet Marburg
Marburg, Germany, 35043
Actively Recruiting
72
Universitatsklinikum Munster
Münster, Germany, 48149
Actively Recruiting
73
St. James Hospital
Dublin, Ireland
Actively Recruiting
74
Azienda Ospedaliero-Universitaria Di Alessandria Ss.Antonio E Biagio E Cesare Arrigo
Alessandria, Italy, 15121
Actively Recruiting
75
Azienda Ospedaliero Universitaria Delle Marche
Ancona, Italy, 60126
Actively Recruiting
76
Aou Policlinico Consorziale Di Bari
Bari, Italy, 70124
Actively Recruiting
77
Asst Degli Spedali Civili Di Brescia
Brescia, Italy, 25123
Actively Recruiting
78
Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco
Catania, Italy, 95123
Actively Recruiting
79
Irccs Azienda Ospedaliera Universitaria San Martino
Genova, Italy, 16132
Actively Recruiting
80
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
81
Ospedale San Raffaele - Milano
Milan, Italy, 20132
Actively Recruiting
82
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Naples, Italy, 80131
Actively Recruiting
83
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, Italy, 90146
Actively Recruiting
84
Irccs Fondazione Policlinico San Matteo
Pavia, Italy, 27100
Actively Recruiting
85
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Reggio Calabria, Italy, 89133
Actively Recruiting
86
Azienda Policlinico Umberto 1 Universita Sapienza Di Roma
Rome, Italy, 00161
Actively Recruiting
87
Ospedale Pediatrico Bambino Gesu Irccs
Rome, Italy, 00165
Actively Recruiting
88
I.R.C.C.S. Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Italy, 71013
Actively Recruiting
89
Azienda Ospedaliera Card. G. Panico
Tricase, Italy, 73039
Actively Recruiting
90
Centro Ricerche Cliniche Di Verona
Verona, Italy, 37134
Actively Recruiting
91
Fujita Health University Hospital
Aichi, Japan, 470-1192
Actively Recruiting
92
Anjo Kosei Hospital
Aichi-ken, Japan, 446-8602
Actively Recruiting
93
Kyushu University Hospital
Fukuoka, Japan
Actively Recruiting
94
Hiroshima University Hospital
Hiroshima, Japan, 734-8551
Actively Recruiting
95
Kobe City Medical Center General Hospital
Hyōgo, Japan, 650-0047
Actively Recruiting
96
Tokai University Hospital
Isehara Kanagawa, Japan, 259-1193
Actively Recruiting
97
National Hospital Organization Kumamoto Medical Center
Kumamoto Kumamoto, Japan, 860-0008
Actively Recruiting
98
Gunma Saiseikai Maebashi Hospital
Maebashi, Japan, 371-0821
Actively Recruiting
99
Tohoku University Hospital
Miyagi, Japan, 980-8574
Actively Recruiting
100
Okayama University Hospital
Okayama Okayama, Japan, 700-0914
Actively Recruiting
101
Osaka Metropolitan University Hospital
Osaka, Japan, 545-8586
Actively Recruiting
102
Hokkaido University Hospital
Sapporo Hokkaido, Japan, 060-0814
Actively Recruiting
103
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Tokyo, Japan, 113-0021
Actively Recruiting
104
Amsterdam University Medical Centre
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
105
Maastricht University Medical Center
Maastricht, Netherlands, 6229 HX
Actively Recruiting
106
Hospital General Universitario Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
107
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
108
Hospital Universitario Donostia
Donostia / San Sebastian, Spain, 20014
Actively Recruiting
109
Institut Catala Doncologia Ico - Hospital Duran I Reynals Location
L'Hospitalet de Llobregat, Spain, 08906
Actively Recruiting
110
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, Spain, 35010
Actively Recruiting
111
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
112
Hospital Puerta de Hierro
Majadahonda, Spain, 28222
Actively Recruiting
113
Hospital Universitario Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
114
Hospital Universitari I Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
115
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
116
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
117
Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
118
Royal Marsden Hospital
London, United Kingdom, SM2 5PT
Actively Recruiting
119
University College London Hospitals (Uclh)
London, United Kingdom, WC1E 6AG
Actively Recruiting
120
Manchester University Nhs Foundation Trust
Manchester, United Kingdom
Actively Recruiting
121
Nottingham University Hospitals
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
122
Plymouth Hospitals Nhs Trust
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
Research Team
I
Incyte Corporation Call Center (US)
I
Incyte Corporation Call Center (ex-US)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here