🏛️ Verified NIH Record • Updated 2026-05-20

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease (NCT06388564)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Incyte Corporation

🩺 Plain-English Summary (8th-Grade Level)

This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (15 items).

Location: Mayo Clinic Hospital — Phoenix, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Received more than 1 prior allo-SCT. Prior autologous HCT is allowed.
  • Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.
  • Received previous systemic treatment for cGVHD, including systemic corticosteroids and extracorporeal photopheresis.
  • Received systemic corticosteroids within 2 weeks prior to C1D1, regardless of indication.
  • Initiated systemic treatment with CNIs or mTOR inhibitors within 2 weeks prior to C1D1.
  • Prior treatment with a JAK inhibitor within 8 weeks before randomization. Participants who received a JAK inhibitor for the treatment of aGVHD are eligible only if they achieved a response (CR or PR) to JAK inhibitor treatment and did not discontinue due to toxicity.
  • Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-SCT was performed, including DLIs for the treatment of molecular relapse.
  • History of acute or chronic pancreatitis.
  • History of thromboembolic events (such as deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction) in the 6 months prior to study entry.
  • Active symptomatic myositis.
  • Severe renal impairment, that is, estimated CrCl \< 30 mL/min measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or end-stage renal disease on dialysis. Participants with CrCl of 30 to 59 mL/min on treatment with fluconazole are not eligible.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (68 Sites)

  • Mayo Clinic Hospital — Phoenix, Arizona
  • City of Hope Medical Center — Duarte, California
  • University of California-Los Angeles Medl Cntr-Oncology Center Bowyer Clinic — Los Angeles, California
  • Stanford Cancer Center — Stanford, California
  • University of Colorado Cancer Center — Aurora, Colorado
  • Colorado Blood Cancer Institute — Denver, Colorado
  • Smilow Cancer Center-Yale — New Haven, Connecticut
  • Mayo Clinic Jacksonville — Jacksonville, Florida
  • Northwestern University — Chicago, Illinois
  • The University of Chicago Medicine — Chicago, Illinois
  • University of Maryland-Greenebaum Cancer Center — Baltimore, Maryland
  • Washington University — St Louis, Missouri
  • Fred and Pamela Buffett Cancer Center — Omaha, Nebraska
  • Memorial Sloan Kettering Cancer Center — New York, New York
  • Weill Cornell Medicine — New York, New York
  • Mount Sinai Hospital — New York, New York
  • Cleveland Clinic — Cleveland, Ohio
  • The Ohio State University — Columbus, Ohio
  • University of Pennsylvania Abramson Cancer Center — Philadelphia, Pennsylvania
  • Hillman Cancer Center — Pittsburgh, Pennsylvania
  • Vanderbilt University Medical Center — Nashville, Tennessee
  • Md Anderson Cancer Center — Houston, Texas
  • Fred Hutchinson Cancer Center — Seattle, Washington
  • University of Washington — Seattle, Washington
  • Froedtert & the Medical College of Wisconsin — Milwaukee, Wisconsin

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗