๐Ÿ›๏ธ Verified NIH Record โ€ข 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

๐Ÿ”ต Active, Not Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Oryzon Genomics S.A.

๐Ÿฉบ 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 โ€” Gilbert, Arizona

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (13 Sites)

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

๐Ÿ“ž 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.

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก 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.
๐Ÿ›๏ธ View Official NIH Record โ†—