Actively Recruiting
Axatilimab for Sclerotic Chronic Graft-versus-Host Disease
Led by Fred Hutchinson Cancer Center · Updated on 2026-03-27
50
Participants Needed
3
Research Sites
235 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests how well axatilimab works in treating patients with thickening or hardening (sclerosis) of the skin related to chronic graft-versus-host disease after a donor stem cell transplant. Chronic graft-versus-host disease (cGVHD) remains a major complication of donor stem cell transplants. Sclerosis, while not associated with a higher risk of death, can lead to serious disabilities. Usual treatments for cGVHD can be associated with significant side effects and unsatisfactory outcomes. A monoclonal antibody, like axatilimab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Axatilimab blocks a receptor and depletes cells that may be involved in the development of inflammation and fibrosis in cGVHD. Giving axatilimab may improve or prevent worsening of sclerosis related to cGVHD in patients after a donor stem cell transplant.
CONDITIONS
Official Title
Axatilimab for Sclerotic Chronic Graft-versus-Host Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 and older
- Ability to understand and sign informed consent
- Received allogeneic stem cell transplant with active chronic graft-versus-host disease needing systemic treatment
- Sclerotic skin score of 2-3 or PROM less than 24 due to cGVHD
- Sclerosis diagnosis within the past 24 weeks
- No new non-corticosteroid systemic immunosuppressive drugs within 28 days before screening unless planned to stop within 21 days after first axatilimab dose
- Allowed corticosteroids at 1 mg/kg prednisone or less daily
- Prior systemic immunosuppression for sclerosis either given for at least 60 days without response or given less than 60 days and stopped or planned to stop within 21 days after first axatilimab dose
- Karnofsky performance status 60% or higher
- Absolute neutrophil count 1.0 x 10^9/L or higher during screening
- Platelet count 50 x 10^9/L or higher without recent transfusion
- Liver function tests within specified limits depending on liver cGVHD status
- Creatinine clearance 30 mL/min or higher
- Willingness to use highly effective contraception during study and for 90 days after last dose if of reproductive potential
You will not qualify if you...
- Hospitalization for infection evaluation or treatment within 28 days before screening
- Significant organ dysfunction making study participation unsuitable
- Taking more than 1 mg/kg/day prednisone or equivalent
- History of non-compliance
- Uncontrolled psychiatric illness limiting study compliance
- Use of investigational agents within 28 days before screening
- Evidence of cancer relapse or post-transplant lymphoproliferative disease at screening
- Diagnosis of other malignancy within 3 years unless previously cured
- Active hepatitis B or hepatitis C infection
- Suspected active or latent tuberculosis
- History of acute or chronic pancreatitis
- History of myositis
- Pregnant or breastfeeding
- Previous treatment with colony stimulating factor 1 receptor therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Not Yet Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
3
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
C
cGVHD Intake Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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