Axatilimab for Sclerotic Chronic Graft-Versus-Host Disease
Fred Hutchinson Cancer Center
Summary
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.
Description
OUTLINE: Patients receive axatilimab IV over 30 minutes on days 1 and 15 of cycles 1-6 and then on day 1 of remaining cycles. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study. Additionally, patients may undergo optional skin biopsies and optional skin flexibility assessments throughout the study. After completion of study treatment, patients are followed up at 30 days then for up to 2 years.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Initial diagnosis of sclerosis within the past 24 weeks (168 days) * No new non-corticosteroid systemic immunosuppressive agent…
Interventions
- BiologicalAxatilimab
Given IV
- ProcedureBiospecimen Collection
Undergo blood sample collection
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureSkin Biopsy
Undergo optional skin biopsy
- ProcedureSkin Measurement
Undergo optional skin flexibility assessment
Locations (3)
- Moffitt Cancer CenterTampa, Florida
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington