Actively Recruiting
A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
Led by Incyte Corporation · Updated on 2026-03-23
120
Participants Needed
70
Research Sites
268 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.
CONDITIONS
Official Title
A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 12 years of age or older at the time of informed consent
- New-onset moderate or severe chronic graft-versus-host disease requiring systemic therapy
- History of one allogeneic stem cell transplant of any donor type, conditioning regimen, or stem cell source
- Adequate blood counts independent of platelet transfusion and growth factors for at least 7 days before study entry: ANC ≥ 0.75 x 10^9/L and platelets ≥ 20 x 10^9/L
- Willingness to avoid pregnancy or fathering children
You will not qualify if you...
- More than one prior allogeneic stem cell transplant; prior autologous transplant allowed
- Presence of overlap chronic graft-versus-host disease with acute features
- Previous systemic treatment for chronic graft-versus-host disease, including corticosteroids and extracorporeal photopheresis
- Systemic corticosteroids within 2 weeks before study day 1
- Started systemic treatment with calcineurin inhibitors or mTOR inhibitors within 2 weeks before study day 1
- Prior JAK inhibitor treatment within 8 weeks before randomization, except those treated for acute GVHD who responded and did not discontinue due to toxicity
- Evidence of relapse or treatment for relapse of the primary hematologic disease after transplant
- History of acute or chronic pancreatitis
- Thromboembolic events within 6 months before study entry
- Active symptomatic myositis
- Severe kidney impairment (creatinine clearance <30 mL/min) or on dialysis; creatinine clearance 30-59 mL/min with fluconazole treatment also excluded
- Impaired liver function (total bilirubin >1.5 times upper limit normal and/or ALT and AST >3 times upper limit normal without liver cGVHD)
- Active significant heart disease such as uncontrolled arrhythmias, uncontrolled hypertension, severe heart failure, or recent heart attack or unstable angina within 6 months
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 70 locations
1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
3
University of California-Los Angeles Medl Cntr-Oncology Center Bowyer Clinic
Los Angeles, California, United States, 90095
Actively Recruiting
4
Stanford Cancer Center
Stanford, California, United States, 94305
Actively Recruiting
5
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
6
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
7
Smilow Cancer Center-Yale
New Haven, Connecticut, United States, 06510
Actively Recruiting
8
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
9
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
10
The University of Chicago Medicine
Chicago, Illinois, United States, 60637
Actively Recruiting
11
University of Maryland-Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
12
Massachusetts General Hospital
Boston, Massachusetts, United States, 02144
Withdrawn
13
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
14
Fred and Pamela Buffett Cancer Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
15
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
16
Weill Cornell Medicine
New York, New York, United States, 10021
Actively Recruiting
17
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
18
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
19
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
20
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
21
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
22
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
23
Md Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
24
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
25
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
26
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
27
Az Sint-Jan Brugge - Oostende Av - Campus Sint-Jan
Bruges, Belgium, 08000
Actively Recruiting
28
Universitair Ziekenhuis Antwerpen (Uza)
Edegem, Belgium, 02650
Actively Recruiting
29
Jessa Ziekenhuis
Hasselt, Belgium, 03500
Actively Recruiting
30
Universitair Ziekenhuis (Uz) Leuven
Leuven, Belgium, 03000
Actively Recruiting
31
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven, Belgium, 03000
Actively Recruiting
32
Centre Hospitalier Universitaire (Chu) de Liege
Liège, Belgium, 04000
Actively Recruiting
33
AZ DELTA
Roeselare, Belgium, 08800
Actively Recruiting
34
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T3N 4N1
Actively Recruiting
35
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
36
Chu Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
37
Vancouver General Hospital
Vancouver, Canada, V5Z1M9
Actively Recruiting
38
Klinikum Der Johann Wolfgang Goethe University
Frankfurt am Main, Germany, 60590
Actively Recruiting
39
Universitatklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
40
Universitatsklinikum Hamburg Eppendorf
Hamburg, Germany, 20251
Actively Recruiting
41
Universitaetsklinikum Jena
Jena, Germany, 07747
Actively Recruiting
42
University Hospital Mannheim
Mannheim, Germany, 68167
Actively Recruiting
43
Universitaetsklinikum Regensburg
Regensburg, Germany, 93053
Actively Recruiting
44
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Bergamo, Italy, 24127
Actively Recruiting
45
Aou Policlinico S. Orsola-Malpighi
Bologna, Italy, 40138
Actively Recruiting
46
Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico Di Milano Uo Dermatologia
Milan, Italy, 20122
Actively Recruiting
47
Ospedale Pediatrico Bambino Gesu Irccs
Rome, Italy, 00165
Actively Recruiting
48
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome, Italy, 00168
Actively Recruiting
49
Irccs Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
50
A.O.U. Citta Della Salute E Della Scienza Di Torino
Torino, Italy, 10126
Actively Recruiting
51
Hospital General Universitario Vall D Hebron
Barcelona, Spain, 08035
Withdrawn
52
Hospital Clinic Barcelona Main
Barcelona, Spain, 08036
Actively Recruiting
53
Hospital Universitario Virgen de La Arrixaca
El Palmar, Spain, 30120
Actively Recruiting
54
Hospital Universitario Virgen de Las Nieves
Granada, Spain, 18014
Actively Recruiting
55
Ico Institut Catala D Oncologia
Granvia de L'hospitalet 199-203, Spain, 08908
Actively Recruiting
56
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
57
Hospital Universitario Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
58
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
59
Hospital Regional Universitario de Malaga
Málaga, Spain, 29011
Actively Recruiting
60
Hospital Clinico Universitario de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
61
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
Actively Recruiting
62
Hospital Universitario Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
63
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
64
Hospital Universitari I Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
65
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
66
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
67
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
68
Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
69
St James University Hospital
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
70
Clatterbridge Cancer Center
Liverpool, United Kingdom, L7 8YA
Actively Recruiting
Research Team
I
Incyte Corporation Call Center (US)
CONTACT
I
Incyte Corporation Call Center (ex-US)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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