A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

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A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Status
Active
Cancer Type
Unknown Primary
Trial Phase
Phase III
Eligibility
12 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06585774
Protocol IDs
INCA34176-357 (primary)
NCI-2025-01061
2023-510292-65-00
Study Sponsor
Incyte Corporation

Summary

This study will be conducted to compare the efficacy of axatilimab versus placebo in
combination with corticosteroids as initial treatment for moderate or severe chronic
graft-versus-host disease (cGVHD).

Eligibility

  1. = 12 years of age at the time of informed consent.
  2. New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy.
  3. History of allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible.
  4. Adequate hematologic function with ANC = 0.5 × 109/L independent of growth factors for at least 7 days prior to study entry.
  5. Willingness to avoid pregnancy or fathering children.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.