Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

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

NCT05546580 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Iadademstat
  • DRUG Gilteritinib Oral Tablet

Study Locations (13)

Arizona

  • Banner MD Anderson Cancer Center — Gilbert
  • The University of Arizona Cancer Center - North Campus — Tucson

Florida

  • Sylvester Comprehensive Cancer Center — Miami
  • Miami Cancer Institute — Miami

Maryland

  • The John Hopkins University School of Medicine — Baltimore

Massachusetts

  • Massachusetts General Hospital (MGH) — Boston

New Jersey

  • Rutgers, The State University — Piscataway

New York

  • Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital — New York

North Carolina

  • Duke University Medical Center — Durham

Oregon

  • Oregon Health & Science University — Portland

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2022-11-14
Est. Completion 2025-11-30
Phase Phase 1

Sponsor

Oryzon Genomics S.A.

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05546580

The ClinicalTrials.gov registry entry for NCT05546580 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oryzon Genomics S.A., which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Acute Myeloid Leukemia, in Relapse appearing as the primary indexed condition, and to 2 interventions — of which Iadademstat is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05546580 reports 13 study locations spanning 11 distinct geographic areas — top geographies include Arizona, Florida, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05546580 about?

NCT05546580 is a clinical study titled "Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)". 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 wi...

What is the current status of trial NCT05546580?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2022-11-14. Estimated completion is 2025-11-30.

What conditions does trial NCT05546580 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05546580?

The interventions under investigation include: Iadademstat (DRUG), Gilteritinib Oral Tablet (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05546580?

This trial is sponsored by Oryzon Genomics S.A., which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05546580 being conducted?

This trial has 13 study locations across Arizona, Florida, Maryland, Massachusetts, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial