Axatilimab for Sclerotic Chronic Graft-versus-Host Disease

Part of paid clinical trials in Tampa, Florida.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT07011810
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Axatilimab — BIOLOGICAL
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Skin Biopsy — PROCEDURE
    Undergo optional skin biopsy
  • Skin Measurement — PROCEDURE
    Undergo optional skin flexibility assessment

Study Details

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.

Key Dates

Start date
Aug 6, 2025
Status verified
Mar 2026
Primary completion
Aug 10, 2028
Completion
Feb 10, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (axatilimab)
    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.

Primary Outcome Measure

Overall response rate (ORR) in sclerotic manifestations [ Time Frame: Up to 24 weeks, cycle 7 day 1 (cycle length = 28 days) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Joseph Pidala, MD, PhD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02115
Corey Cutler, MD, MPH (PRINCIPAL_INVESTIGATOR)
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
cGVHD Intake Coordinator
[email protected]
206-667-4160
Stephanie J. Lee, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Moffitt Cancer Center· Tampa, FLDana-Farber Cancer Institute· Boston, MAFred Hutch/University of Washington Cancer Consortium· Seattle, WA

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