NCT07011810 · Fred Hutchinson Cancer Center
Axatilimab for Sclerotic Chronic Graft-versus-Host Disease
What this study 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.
View original scientific description
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.
Interventions
BIOLOGICAL
Axatilimab
Given IV
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
OTHER
Questionnaire Administration
Ancillary studies
PROCEDURE
Skin Biopsy
Undergo optional skin biopsy
PROCEDURE
Skin Measurement
Undergo optional skin flexibility assessment
Primary outcome measures
Overall response rate (ORR) in sclerotic manifestations
Time frame: Up to 24 weeks, cycle 7 day 1 (cycle length = 28 days)
Will be defined as the proportion of patients with objective response per 2014 National Institutes of Health (NIH) skin and joint criteria.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 within 28 days prior to screening, unless there is a plan to stop them no later than 21 days after the first dose of axatilimab. Receipt of systemic corticosteroids ≤ 1 mg/kg prednisone or prednisone equivalent daily is allowed at the time of enrollment and may be continued after axatilimab initiation
- If patient has been previously treated with systemic immunosuppression for sclerosis, one of th
Where
- Tampa, Florida
- Boston, Massachusetts
- Seattle, Washington
Collaborators
Incyte Corporation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations