🏛️ Verified NIH Record • Updated 2026-08-21

A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256) (NCT07124078)

A Phase 2, Randomized, Open-Label Study of Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Incyte Corporation

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

This study will be conducted to compare Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.

Who can join: Review the eligibility criteria below.

Location: City of Hope Medical Center — Duarte, California

Age range: 2 Years to 17 Years

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

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (41 Sites)

Showing the first 25 of 41 sites.

  • City of Hope Medical Center — Duarte, California
  • Children'S Hospital Los Angeles Specialt — Los Angeles, California
  • Lucile Packard Child Hospital End — Palo Alto, California
  • Childrens National Medical Center — Washington D.C., District of Columbia
  • Adventhealth Pediatric Cellular Therapy and Blood and Marrow Transplant — Orlando, Florida
  • Childrens Healthcare of Atlanta — Atlanta, Georgia
  • Memorial Sloan Kettering Cancer Center — New York, New York
  • Levine Cancer Institute — Charlotte, North Carolina
  • Duke Cancer Center — Durham, North Carolina
  • Childrens Hospital of Pittsburgh — Pittsburgh, Pennsylvania
  • Fred Hutchinson Cancer Research Center — Seattle, Washington
  • Hôpital Universitaire Des Enfants Reine Fabiola — Brussels,
  • Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc — Woluwe-Saint-Lambert,
  • Charite Campus Virchow — Berlin,
  • Klinikum Der Johann Wolfgang Goethe-Universitaet — Frankfurt am Main,
  • Universitaetsklinikum Freiburg Kinder- Und Jugendklinik (Kjk) — Freiburg im Breisgau,
  • Universitaetsklinikum Hamburg-Eppendorf — Hamburg,
  • Medizinische Hochschule Hannover (Mhh) - Zentrum Fuer Kinderheilkunde Und Jugendmedizin - Klinik Fue — Hanover,
  • University Hospital Regensburg — Regensburg,
  • Irccs - Aou Di Bologna - Sant'Orsola Malpighi — Bologna,
  • Irccs Istituto G. Gaslini, Universita Di Genova — Genova,
  • Fondazione Irccs San Gerardo Dei Tintori — Monza,
  • Azienda Ospedaliera Universitaria Di Padova — Padua,
  • Fondazione Irccs Policlinico San Matteo Di Pavia Oncoematologia Pediatrica, Universita Di Pavia — Pavia,
  • Irccs Ospedale Pediatrico Bambino Gesu — Rome,

📞 Contact the Study Coordinator

Phone: (855) 463-3463

Email: medinfo@incyte.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗