🏛️ Verified NIH Record • Updated 2026-08-21

Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+) (NCT05546580)

An Escalation/Expansion, Open Label, Multicenter Study of Iadademstat and Gilteritinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+): The FRIDA Study

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Oryzon Genomics S.A.

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

Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) with FMS-like tyrosine kinase mutation (FLT3 mut+). During the trial, iadademstat will be given in combination with gilteritinib, a drug that is already approved to treat patients with FLT3-mutated R/R AML.

Who can join: Review the eligibility criteria below.

Location: Banner MD Anderson Cancer Center — Gilbert, Arizona

Age range: 18 Years

🧪 Interventions in This Study

📋 "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 (13 Sites)

  • Banner MD Anderson Cancer Center — Gilbert, Arizona
  • The University of Arizona Cancer Center - North Campus — Tucson, Arizona
  • Sylvester Comprehensive Cancer Center — Miami, Florida
  • Miami Cancer Institute — Miami, Florida
  • The John Hopkins University School of Medicine — Baltimore, Maryland
  • Massachusetts General Hospital (MGH) — Boston, Massachusetts
  • Rutgers, The State University — Piscataway, New Jersey
  • Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital — New York, New York
  • Duke University Medical Center — Durham, North Carolina
  • Oregon Health & Science University — Portland, Oregon
  • Sarah Cannon Research Institute, LLC — Nashville, Tennessee
  • West Virginia University — Morgantown, West Virginia
  • Froedtert Hospital & The Medical College of Wisconsin — Milwaukee, Wisconsin

📞 Contact the Study Coordinator

Phone: (877) 632-6789

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 ↗