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NCT05546580 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, sponsored by Oryzon Genomics S.A..

Recruiting
Registry status
Phase 1
Development phase
50
Enrollment target
13
Study locations

NCT05546580: Recruiting Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, sponsored by Oryzon Genomics S.A..

NCT05546580 is a Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory that is actively recruiting participants, run by Oryzon Genomics S.A.. The registered enrollment target is 50 participants, below the 57-participant average among 16 other Acute Myeloid Leukemia, in Relapse trials with a reported enrollment target (12% lower). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05546580, a Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, is actively recruiting participants, sponsored by Oryzon Genomics S.A..

RECRUITING
Registry status
Phase 1
Development phase
50 participants
Enrollment target
13
Study locations

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.

Primary Outcome

Number of participants with Adverse Events (AE) after treatment with iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML.

Conditions Studied

Acute Myeloid Leukemia, in Relapse Acute Myeloid Leukemia Refractory

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
Oryzon Genomics S.A.

3 total trials

What NCT05546580 shows while recruiting

NCT05546580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 57-participant average among 16 other Acute Myeloid Leukemia, in Relapse trials with a reported enrollment target (12% lower).

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.

NCT05546580 lists 13 locations in 11 states (Arizona, Florida, Maryland).

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.

What interventions are being tested in trial NCT05546580?

The interventions under investigation include: Iadademstat (DRUG), Gilteritinib Oral Tablet (DRUG).

Who is sponsoring clinical trial NCT05546580?

This trial is sponsored by Oryzon Genomics S.A., which has 3 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Acute Myeloid Leukemia, in Relapse

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05546580's enrollment target sits among peer trials

50 3rd of 16 higher than 14 of 16 other Acute Myeloid Leukemia, in Relapse trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Myeloid Leukemia, in Relapse trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05546580

Source: ClinicalTrials.gov NCT05546580, the US trial registry maintained by the National Library of Medicine. NCT05546580 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.