About this trial
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.
Eligibility criteria
Qualifiers
Adults aged 18 and older
Ability to understand and willingness to sign a written informed consent document
Allogeneic stem cell transplant, with active cGVHD requiring systemic treatment. Active cGVHD is defined as the presence of signs and symptoms of cGVHD diagnosed per the 2014 National Institutes of Health (NIH) Consensus Development Project on Criteria for Clinical trials in cGVHD
Sclerotic skin score 2-3 or PROM < 24 due to cGVHD
Disqualifiers
Hospitalization for evaluation or management of an infection within 28 days prior to screening
History or other evidence of significant organ dysfunction that would make the patient, in the opinion of the investigator, unsuitable for the study
On more than 1 mg/kg/day prednisone or prednisone equivalent
History of non-compliance
Trial design
Treatments tested in this trial
- Axatilimab
- Biospecimen Collection
- Questionnaire Administration
- Skin Biopsy
- Skin Measurement
Treatment groups
Sponsors and collaborators
Fred Hutchinson Cancer Center
Lead sponsor
Incyte Corporation
Collaborator